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AashishTiwari/Drug Enforcement and Recall.ipynb

Created March 23, 2017 18:47
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Drug Enforcement and Recall.ipynb
{
"cells": [
{
"cell_type": "markdown",
"metadata": {},
"source": [
"## Clustering Drug Recall and Enforcement Topics.\n",
"#### Topic Mining: Visualizing topics in text with LDA\n",
"\n",
"#### **AI LAB TEAM** - Persistent Systems Ltd.\n"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"## Table of contents\n",
"\n",
"\n",
"1. [Step 1: Environment Setup](#Step-1:-Environment-Setup)\n",
"\n",
"2. [Step 2: Data acquisition from OpenFDA](#Step-2:-Data-acquisition-from-OpenFDA)\n",
"\n",
"3. [Step 3: Data analysis](#Step-3:-Data-analysis)\n",
" - [Data discovery](#Data-discovery)\n",
" - [Text processing : tokenization](#Text-processing-:-tokenization)\n",
" - [Text processing : tf-idf](#Text-processing-:-tf-idf)\n",
"\n",
"4. [Step 4: Clustering](#Step-4:-Clustering)\n",
" - [KMeans](#KMeans)\n",
" - [Latent Dirichlet Allocation](#Latent-Dirichlet-Allocation)\n",
" - [Visualization of the topics using pyLDAvis](#Visualization-of-the-topics-using-pyLDAvis)\n",
"\n",
"5. [Step 5: Conclusion](#Step-5:-Conclusion)\n",
"\n",
"6. [Step 6: References](#Step-6:-References)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"### Introduction"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"## Step 1: Environment Setup"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"[[ go back to the top ]](#Table-of-contents)\n",
"\n",
"We suggest downloading the Anaconda distribution for python 3.6 from this <a href=\"https://www.continuum.io/downloads\">link</a>. This distribution wraps python with the necessary packages used in data science like Numpy, Pandas, Scipy or Scikit-learn.\n",
"\n",
"For the purpose of this tutorial we'll also have to download external packages:\n",
"\n",
"- **tqdm** (a progress bar python utility) from this command: pip install tqdm\n",
"- **nltk** (for natural language processing) from this command: conda install -c anaconda nltk=3.2.2\n",
"- **bokeh** (for interactive data viz) from this command: conda install bokeh\n",
"- **lda** (the python implementation of Latent Dirichlet Allocation) from this command: pip install lda\n",
"- **pyldavis** (python package to visualize lda topics): pip install pyldavis\n",
"\n",
"To connect to the Newsapi service you'll have to create an account at https://newsapi.org/register to get a key. It's totally free. Then you'll have to put your key in the code and run the script on your own if you want to. "
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"## Step 2: Data acquisition from OpenFDA"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"[[ go back to the top ]](#Table-of-contents)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"https://open.fda.gov/downloads/\n",
"The JSON file resulting from this response download is pretty straightforward:"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"```\n",
"{\n",
" \"classification\": \"Class II\",\n",
" \"center_classification_date\": \"20170315\",\n",
" \"report_date\": \"20170322\",\n",
" \"postal_code\": \"92117-7310\",\n",
" \"recall_initiation_date\": \"20170210\",\n",
" \"recall_number\": \"D-0546-2017\",\n",
" \"city\": \"San Diego\",\n",
" \"event_id\": \"76472\",\n",
" \"distribution_pattern\": \"Nationwide within the United States\",\n",
" \"openfda\": {},\n",
" \"recalling_firm\": \"Synergy Rx\",\n",
" \"voluntary_mandated\": \"Voluntary: Firm Initiated\",\n",
" \"state\": \"CA\",\n",
" \"reason_for_recall\": \"Lack of Assurance of Sterility: There are also CGMP Deviations. \",\n",
" \"initial_firm_notification\": \"Telephone\",\n",
" \"status\": \"Ongoing\",\n",
" \"product_type\": \"Drugs\",\n",
" \"country\": \"United States\",\n",
" \"product_description\": \"VITAMIN K OXIDE 5%, HQ 4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676\",\n",
" \"code_info\": \" All Lots\",\n",
" \"address_1\": \"4901 Morena Blvd Ste 504A\",\n",
" \"address_2\": \"\",\n",
" \"product_quantity\": \"\"\n",
" }\n",
"```"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Let's get into the code to see how to manage this data acquisition:"
]
},
{
"cell_type": "code",
"execution_count": 4,
"metadata": {
"collapsed": true
},
"outputs": [],
"source": [
"# import packages\n",
"import requests\n",
"import pandas as pd\n",
"from datetime import datetime\n",
"from tqdm import tqdm\n",
"from matplotlib import pyplot as plt\n",
"import json"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"In this post, we'll be analyzing english news sources only. "
]
},
{
"cell_type": "code",
"execution_count": 17,
"metadata": {
"collapsed": true
},
"outputs": [],
"source": [
"def get_reason_for_recall():\n",
" all_recalls = []\n",
" with open('drug-enforcement-0001-of-0001.json') as data_file: \n",
" data = json.load(data_file)\n",
" for res in data['results']:\n",
" recalls = [uniq_reason for uniq_reason in res['reason_for_recall'].split(';')]\n",
" all_recalls.extend(recalls)\n",
" return set(all_recalls)"
]
},
{
"cell_type": "code",
"execution_count": 19,
"metadata": {
"collapsed": false
},
"outputs": [
{
"name": "stdout",
"output_type": "stream",
"text": [
"number of unique reasons : 2602\n",
"Reasons : {'', 'Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.', 'Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.', ' some lots failed Antimicrobial Effectiveness Testing on stability', 'Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.', 'Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing. ', 'Failed Dissolution Specifications', ' THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD54559_1, EXP: 5/20/2014. ', ' lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume. ', ' QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24/2014', ' The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.', 'Resuspension Problems: Recalled lot did not meet resuspendability requirements.', ' HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD49582_16, EXP: 5/16/2014.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014', 'Superpotent drug: Out of specification test result for assay during stability testing.', 'Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.', ' OMEGA-3 FATTY ACID, Capsule, 100', 'Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.', 'Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A. ', \"The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.\", ' white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. ', 'Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, NDC 11523726503, Pedigree: AD42584_15, EXP: 5/14/2014. ', 'Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD32582_3, EXP: 5/9/2014. ', 'Failed pH Specifications: 12 month stability testing', 'Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. ', ' DOCUSATE SODIUM', ' Beta carotene (Vitamin A)', ' MELATONIN, Tablet, 3 mg, ND', 'Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014', 'Failed Impurities/Degradation Specifications: Out of specifications results for impurities.', 'Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.', 'Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.', 'Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.', 'Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.', ' METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W002841, EXP: 6/7/2014', 'Failed Impuities/Degradation Specifications', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014', ' Error on Declared Strength', 'Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements. ', 'CGMP Deviations: Product excipient was not re-tested at the appropriate date.', ' all compounded products within expiry produced using recalled filters', 'First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).', 'Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.', 'Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.', 'Labeling Wrong Barcode', 'Subpotency: product assayed and found OOS for cyproheptadine', 'Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.', ' METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014', 'Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as the following drug: MERCapsuleTOPURINE, Tablet, 50 mg, NDC 00054458111, Pedigree: AD54549_1, EXP: 5/20/2014.', 'Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014. ', 'Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.', 'Failed Tablet Specifications: Broken Tablets Present.', 'Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.', 'Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.', 'Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.', 'Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD21846_31, EXP: 5/1/2014', ' LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014', ' LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014', 'Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.', ' Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.', 'Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg ', ' NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.', 'Impurity/Degradation', 'Incorrect/Undeclared Excipient', ' chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70700_1, EXP: 5/29/2014', 'Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil', 'Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.', '2)', 'Failed Lozenge Specifications', 'Superpotent Drug: one ingredient was found to be above assay specification.', 'Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD33897_4, EXP: 5/9/2014', ' VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014', ' ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014. ', ' fine residue or dust identified as aluminum may be on exterior of the capsule shell', ' NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014.', ' VENLAFAXINE, Tablet, 25 mg', ' CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially mislabeled as TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD21858_10, EXP: 5/1/2014.', ' CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014', ' Expiration date is earlier than listed on vial.', 'CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.', 'Failed Impurities/Degradations Specifications', 'Subpotent Drug: menthol and methyl salicylate below specification', ' PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBACILLUS ACIDOPHILUS, Capsule, NDC 54629011101, Pedigree: AD65311_4, EXP: 5/24/2014.', ' positive findings of Burkholderia cepacia', 'SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.', 'Lack of Assurance of Sterility: all sterile compounded products within expiry ', 'Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.', 'Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.', ' microbial contamination with B. cepacia', ' CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: W002844, EXP: 6/7/2014', 'Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement', 'Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.', ' phenylephrine HCl', 'Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles. ', 'Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil', 'Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.', \"Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory\", ' CHLORTHALIDONE, Tablet, 50 mg, NDC 00378021301, Pedigree: W002988, EXP: 6/11/2014', 'Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.', 'Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.', ' CLINDAMYCIN HCL, Capsule, 300 mg, NDC 00591312001, Pedigree: AD67989_1, EXP: 5/28/2014. ', 'Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.', ' This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014. ', ' product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug', 'Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as the following drug: ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD25264_1, EXP: 5/3/2014. ', 'Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.', ' PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD42584_12, EXP: 5/14/2014.', ' VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD60211_20, EXP: 5/21/2014', 'Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.', ' PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014', \"Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. \", ' LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD65311_1, EXP: 5/24/2014', 'Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033', ' ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014', 'Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.', 'Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.', 'Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.', ' FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014', 'Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.', 'Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.', 'Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.', 'Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.', 'Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).', ' CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014', ' potential for incomplete constitution upon addition of diluent. ', ' carBAMazepine ER, Capsule, 200 mg, NDC 66993040832, Pedigree: AD32764_14, EXP: 5/14/2014', ' DOCUSATE SODIUM, Capsule, 50 mg, N', 'Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.', 'Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. ', ' possibility of Glipizide 10 mg tablet in bottle', ' product was found to contain undeclared sibutramine & phenolphthalein', 'Chemical contamination: emission of strong odor after package was opened.', ' RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD60272_40, EXP: 5/22/2014', 'Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.', ' Product recalled due to displacement of the aluminum crimp cap during product usage.', ' VENLAFAXINE HCL Tablet, 50 mg may be potentially mislabeled as sulfaSALAzine, Tablet, 500 mg, NDC 00603580121, Pedigree: AD65475_19, EXP: 5/28/2014.', 'Failed Content Uniformity Specifications: out of specification test result for spray content uniformity. ', 'Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.', 'Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).', ' high out of specification for CAD II degradant', 'Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.', 'Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017', 'Stability data does not support expiry. ', ' during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy', 'Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.', 'Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.', ' OMEGA-3-ACID ETHYL ESTERS, Capsu', 'Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, 0 mg, NDC 24208063210, Pedigree: AD21846_40, EXP: 5/2/2014', ' COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W002819, EXP: 6/7/2014.', 'Failed Dissolution: Out of Specification test results (low) at the 18 month time-point.', ' tiZANidine HCl, Tablet, 2 mg, NDC 00378072219, Pedigree: W002975, EXP: 6/11/2014. ', 'Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.', 'Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry). ', 'CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.', ' All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.', 'Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. ', 'Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.', 'Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.', ' ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.', ' guanFACINE HCl, ', 'Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.', ' ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: W003474, EXP: 6/20/2014', 'Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point', ' prednisoLONE, Tablet, 5 mg, NDC 16477050501, Pedigree: W003627, EXP: 6/25/2014. ', 'Chemical contamination: Product may be contaminated with a toxic compound.', ' CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD54586_10, EXP: 5/21/2014. ', 'Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.', ' PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014. ', 'Lack of Assurance of Sterility: All compounded products.', ' FDA inspection identified GMP violations potentially impacting product quality and sterility', ' deficiencies at the manufacturer may result in assay or content uniformity failures', ' FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014. ', ' THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014', 'Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.', 'Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.', ' Missing label', ' CHOLECALCIFEROL Capsule, 50000 units may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD60272_64, EXP: 5/22/2014.', 'Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.', \"Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.\", ' FOLIC ACID, Tablet, 1 mg, NDC 65162036110,', 'Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial', 'Presence of Particulate Matter: glass delamination', 'Failed Stability Specifications', 'Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: OXcarbazepine, Tablet, 150 mg, NDC 62756018388, Pedigree: AD54562_4, EXP: 5/20/2014. ', 'Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: AD30180_4, EXP: 5/8/2014', 'Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 50 mg may have potentially been mislabeled as the following drug: SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W002979, EXP: 6/11/2014.', \"Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.\", 'Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.', ' CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904', 'Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot. ', 'Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.', ' medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD46312_13, EXP: 5/16/2014.', 'Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.', 'Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: PHENOL, LOZENGE, 29 mg, NDC 00068021918, Pedigree: AD49582_13, EXP: 5/16/2014', 'Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. ', ' Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.', ' VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD49414_7, EXP: 5/17/2014. ', 'Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.', 'Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint. ', ' MELATONIN, Tablet, 3 mg, NDC', ' leaking around the cap', 'FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. ', 'Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.', ' Listed active ingredient strength is inaccurate. ', 'Marketed without an Approved NDA/ANDA', ' PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, 0 mg, NDC 51991056601, Pedigree: AD73597_1, EXP: 5/31/2014. ', ' MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014', 'Active ingredient (in each capsule)&quot', 'Labeling: Wrong Bar Code', 'Lack of Assurance of Sterility - the firm is recalling select sterile drug products.', 'Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride. ', ' NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W002766, EXP: 6/6/2014', 'Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.', 'Labeling: Label Mixup: CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003460, EXP: 6/20/2014', ' product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct ', ' report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP ', 'Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. ', ' VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014', ' CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053', 'Labeling: Label Mixup: PHENobarbital, Tablet, 64.8 mg may have potentially been mislabeled as the following drug: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD73518_4, EXP: 5/31/2014. ', 'Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.', ' FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), NDC 00904759160, Pedigree: AD54553_1, EXP: 5/20/2014', ' LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 54092025290, Pedigree: W002790, EXP: 6/6/2014', ' CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD30180_25, EXP: 5/9/2014', ' microbial contamination identified as Aspergillus species', ' MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD73', 'Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.', 'CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.', 'Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. ', 'Chemical contamination: emission of strong odor after package was opened..', 'Stability Data Does Not Support Expiry', 'Lack of assurance of sterility', 'Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.', 'Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.', ' DARUNAVIR, Tablet, 800 mg, NDC 59676056630, Pedigree: W003929, EXP: 7/1/2014. ', ' out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)', ' CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002767, EXP: 6/6/2014', 'Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00781570192, Pedigree: AD21965_10, EXP: 5/1/2014', 'Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.', ' LISINOPRIL Tablet, 2.5 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD23087_1, EXP: 5/2/2014', ' ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.', 'Labeling: Label Mixup: VENLAFAXINE HCL ER, Capsule, 150 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD30993_17, EXP: 5/9/2014', 'Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.', ' SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014', 'Labeling: Incorrect instructions', 'Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.', 'cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.', \"Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.\", ' LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD60272_73, EXP: 5/22/2014', ' LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014', ' METOPROLOL TARTRATE, Tablet, 25 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003826, EXP: 6/27/2014', ' CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014. ', 'Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as the following drug: BUMETANIDE, Tablet, 1 mg, NDC 00093423301, Pedigree: W003224, EXP: 6/17/2014. ', 'Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.', 'Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold', 'Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.', 'The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.', ' 18 month stability time point', 'Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.', 'Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.', ' out-of-specification for color, impurity, and degradation', ' guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014', 'Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.', ' FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003086, EXP: 6/12/2014.', 'cGMP Deviation', 'Labeling: Label Mixup: ACYCLOVIR, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD60240_51, EXP: 5/22/2014', 'Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 750 mg, NDC 00536703301, Pedigree: AD46414_56, EXP: 5/16/2014. ', 'Labeling: Label Mixup: THIOTHIXENE, Capsule, 1 mg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD46257_1, EXP: 5/15/2014.', 'Lack of Assurance of Sterility', ' MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentially mislabeled as ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: AD22858_1, EXP: 3/31/2014.', ' 6 month time point ', 'CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.', 'Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck. ', ' improperly crimped fliptop vials', ' Certain information was inadvertently excluded from the product carton label.', 'Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.', 'Lack of Sterility Assurance: The product has the potential to leak at the administrative port.', ' RILUZOLE, Tablet,', ' guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014', 'Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014', ' LEVOTHYROXINE SODIUM, Tablet, 175 ', ' customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER', ' 22 month stability timepoint', 'Labeling: Label mix-up', 'Temperature Abuse', 'Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.', 'Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin. ', 'Presence of particulate.', ' red and black particulate within the solution and embedded within the plastic vial identified as iron oxide', 'Failed Impurities/ Degradation Specifications ', 'Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.', ' Drug product leaking from container therefore sterility cannot be assured', ' PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC ', ' product labeled did not indicated Extended Release ', ' TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg, NDC 00074706890, Pedigree: AD70633_4, EXP: 5/23/2014.', 'Short Fill: The product is being recalled due to a potential underfill of the affected vials.', 'Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled', 'Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.', 'Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.', ' CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD46265_10, EXP: 5/15/2014.', 'Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.', 'Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.', 'Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.', 'Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein', ' glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD30140_34, E', ' SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003591, EXP: 6/24/2014.', 'Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules', ' PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003061, EXP: 5/31/2014. ', ' packages labeled as Thiamine actually contain Diltiazem Capsules ', 'Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.', ' visible crystals from the active ingredient formed due to extreme cold temperatures during shipping', 'Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.', ' ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60', ' OXYBUTYNIN CHLORIDE, Tablet, ', ' METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.', ' LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: W003847, EXP: 6/27/2014', 'Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.', ' ampoules are missing the immediate container label', 'Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.', 'Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014. ', 'Non-Sterility: fungal contamination due to leaking containers.', 'Failed Content Uniformity Specifications.', 'Discoloration', 'Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).', ' laboratory testing was not followed in accordance with GMP requirements', ' SODIUM CHLORIDE, Tabl', ' CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014', 'Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.', ' small amounts of diphenhydramine precipitated out of solution', 'Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. ', ' FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP: 5/1/2014', ' VENLAFAXINE HCL', ' contamination with Burkholderia cepacia (manufacturer) ', ' ATOMOXE', ' AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014', 'Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.', 'Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.', ' the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream. ', ' The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.', 'Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003725, EXP: 6/26/2014. ', ' FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.', ' LACTOBACILLUS ACIDOPHILUS, Tablet, 35 Million, NDC 00536718101, Pedigree: W003865, EXP: 6/27/2014', 'Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.', ' 18 month stability time point ', ' MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014', ' PARoxetine HCl, Tablet, 10 mg may be potentially mislabeled as PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 62175018046, Pedigree: AD52778_64, EXP: 5/20/2014.', 'Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.', 'Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003473, EXP: 6/20/2014. ', ' out of specification results for Maximum Unknown Impurities and Total Impurities', ' exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&amp', ' ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled \"01AUG1017\" rather than \"01AUG2017\".', ' 6 month time point', 'Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.', ' guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003931, EXP: 6/28/2014', 'Presence of Particulate Matter: particulate matter was found during the manufacturing process.', ' PARoxetine HCl, Tablet, 10 mg, NDC 13107015430, Pedigree: AD52778_67, EXP: 5/20/2014. ', 'Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. ', ' LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014. ', 'Labeling: Incorrect or Missing Lot and/or Expiration Date', 'Products failed the Antimicrobial Effectiveness Test. ', ' NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014', 'Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.', 'Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as one of the following drugs: ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: AD21811_10, EXP: 5/2/2014', ' PROPRANO', 'Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.', ' VITAMIN B COMPLEX PROLONGED RELEASE Tablet may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD73627_23, EXP: 5/30/2014', 'Presence of Particulate Matter: Cardboard', 'Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. ', 'Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.', 'Labeling: Label Mixup: DOXAZOSIN MESYLATE, Tablet, 1 mg may have potentially been mislabeled as the following drug: PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: W003872, EXP: 6/27/2014. ', 'Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.', 'Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.', 'Presence of Foreign Tablet', ' DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014.', ' product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug', 'Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.', ' QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD49426_1, EXP: 5/16/2014.', 'Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect \"Compounded\"\\x1d date, lot number, and \\x1c\"Do Not Use Beyond\\x1d\" date or BUD (Before Use Date) that may be longer than intended.', 'Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.', ' container closure issues with the bulk batch. ', 'Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.', 'CGMP Deviations: Firm did not adequately investigate customer complaints.', 'Discoloration: Firm received complaints of product discoloration and particulates.', 'Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. ', ' Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. ', 'Defective Container: Product lacks tamper evident breakaway band on cap.', 'Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.', 'CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.', 'Failed Impurities/Degradation Specifications: Product failed a known impurity specification.', 'Failed Stability Specifications: Two lots of Alprazolam 0.25 mg tablets, were found to be below specification for assay (potency). ', ' PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.', 'Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 1 mg, NDC 16714058701, Pedigree: W003150, EXP: 6/13/2014.', ' LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014', ' 15-month stability test station', 'Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, NDC 00904506260, Pedigree: AD28333_1, EXP: 5/8/2014', 'Labeling: Incorrect or Missing Lot and/or Exp Date', 'Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)', ' OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014', 'Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.', 'Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.', ' GLUCOSAMIN', ' L', 'Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD68010_1, EXP: 5/28/2014', ' 24 month stability test station', 'Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.', 'Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.', ' DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD49610_1, EXP: 5/16/2014', ' ATORVASTATIN CALCIUM Tablet, 20 mg may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003850, EXP: 6/27/2014.', ' 18 month CRT', 'Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.', ' NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014. ', 'Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.', 'Incorrect Expiration Date: The \"11/06\" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)', 'Subpotent Drug: The products were below specification for potency at the expiry stability point.', ' PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014. ', \"Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. \", ' SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014', ' MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014. ', ' buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.', ' may contain glass particles', 'Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.', 'Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.', 'Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ', ' ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD52993_25, EXP: 5/20/2014.', 'Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD73525_31, EXP: 5/30/2014', 'CGMP Deviation', 'Labeling: Label Mixup: ACYCLOVIR, Tablet, 800 mg may have potentially been mislabeled as the following drug:\\t PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 64679043304, Pedigree: AD70690_4, EXP: 5/29/2014. ', 'Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.', ' ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD21846_49, EXP: 5/1/2014. ', 'Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. ', 'Failed Dissolution Specifications: OOS result during stability testing', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2', 'Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.', ' MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as SELEGILINE HCL, Capsule, 5 mg, NDC 67253070006, Pedigree: AD54549_19, EXP: 5/20/2014', 'Labeling: Label Mixup: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD65475_25, EXP: 5/28/2014. TRI-BUFFERED ASPIRIN, Tablet, 325 mg, NDC 00904201559, Pedigree: W003581, EXP: 6/24/2014. ', ' Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.', ' DESIPRAMINE HCL, Tablet, 50 mg, NDC 45963034302, Pedigree: AD30140_7, EXP: 5/7/2014. ', ' Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.', ' benzophenone leached from the product label varnish', 'Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.', 'Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)', 'Labeling: Label Mixup: GABAPENTIN, Tablet, 600 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD21965_1, EXP: 5/1/2014.', 'Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of the following drugs: FEXOFENADINE HCL, Tablet, 180 mg, NDC 41167412003, Pedigree: AD62834_1, EXP: 5/23/2014', ' HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.', 'Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.', 'Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. ', ' MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LISINOPRIL, Tablet, 2.5 mg, NDC 64679092701, Pedigree: AD25264_4, EXP: 5/3/2014.', ' DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014', 'Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.', 'Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110, Pedigree: AD49448_7, EXP: 5/17/2014. ', ' FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), NDC 00904759160, Pedigree: W002717, EXP: 6/6/2014. ', 'Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.', 'Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1000 mg may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: W003925, EXP: 7/1/2014. ', 'Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.', 'Presence of Particulate Matter: Glass particulate found in sterile injectable product', 'Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.', ' Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.', ' LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: W003439, EXP: 6/20/2014', 'Superpotent Drug: High out of specification results for assay at the 6 month time point interval.', 'Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 500 mg, NDC 60258014101, Pedigree: AD23082_19, EXP: 5/6/2014', 'Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.', 'Labeling: incorrect or missing lot number and/or expiration date', 'Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station', 'CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. ', ' guanFACIN', 'Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card', ' NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD25452_1, EXP: 4/30/2014.', 'Chemical Contamination', 'CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.', 'Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.', 'Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. ', 'Misbranded', ' found to contain Lorcaserin, a controlled substance used for weight loss', 'Failed Dissolution Specification: Out of specification dissolution results when testing product stability.', 'A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified. ', 'Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) ', 'Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.', 'CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.', ' product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction', 'Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point ', 'Defective Delivery System: One lot exceeded the mechanical peel specification', 'Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.', ' D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD52993_19, EXP: 5/20/2014.', ' HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014', 'Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.', 'Label Mix up', ' ASPIRIN Tablet, 325 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002642, EXP: 6/4/2014.', 'Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.', 'Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as one of the following drugs: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 00574022201, Pedigree: W003152, EXP: 4/30/2014. ', ' white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.', 'Labeling: Label Mix up', ' LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014', 'Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients', 'Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014', 'Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.', 'Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed ', 'Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.', 'Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014', ' FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014', ' SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014', 'Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.', 'Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.', ' cotton coil is missing in some packaged bottles', ' potential for mold contamination', 'Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.', ' or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014. ', 'Labeling: label error on declared strength. ', ' BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014', ' DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014', 'Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.', 'Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 25 mg may have potentially been mislabeled as the following drug: DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree AD54587_4, EXP: 5/21/2014. ', ' MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014', ' Label Mixup', 'Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: W003213, EXP: 6/14/2014', ' TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003352, EXP: 3/31/2014. ', ' BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.', 'Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.', ' tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014', 'Presence of Foreign Substance', 'Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014', ' three month stability time point. ', ' out of specification results at the 9 month stability time point for color, dissolution and related compounds. ', 'Lack of Assurance of Sterility: The firm is recalling all sterile preparations of Estradiol and Testosterone that are within expiry due to deficient practices which may have an impact on sterility assurance. \\t ', ' Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.', 'Failed Tablet/Capsule Specifications: Broken tablets', 'Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD52778_37, EXP: 5/20/2014', ' MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014', ' acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: W003524, EXP: 6/21/2014', 'Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.', 'Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.', 'Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.', ' PIMOZIDE, Tablet, 2 mg, NDC 57844018701, Pedigree: AD30140_43, EXP: 5/7/2014', 'Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 10 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD70585_1, EXP: 5/29/2014.', 'CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. ', 'Defective Container: Product leaks when inverted.', 'Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer', 'Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. ', ' OM', ' complaints of mold in the overpouch', 'Failed Impurities/Degradation Specifications: Out of specification for a known degradant.', ' missing label on blister card ', ' PHOSPHORUS Tablet, 250 mg may be potentially mislabeled as CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: AD56921_1, EXP: 5/21/2014', ' LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014', ' PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014', ' MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00527134601, Pedigree: AD60272_22, EXP: 5/22/2014', 'Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.', ' bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)', 'Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.', 'GMP deficiencies ', 'Failed Impurities/Degradation Specifications: during long-term stability testing. ', 'CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.', 'Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset', ' guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W002734, EXP: 6/6/2014', ' aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP: 5/22/2014', 'Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection', ' COLCHICINE, ', 'Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.', 'Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014', 'Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.', ' ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD73627_1, EXP: 5/30/2014', 'Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD65457_19, EXP: 5/24/2014', ' PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.', 'Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 64679071401, Pedigree: AD28355_1, EXP: 5/8/2014', 'Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.', 'Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003017, EXP: 6/12/2014. ', ' CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014', ' HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014', ' HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003325, EXP: 6/18/2014. ', ' FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014. ', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine', ' TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: W002976, EXP: 6/11/2014', 'Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.', \" Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. \", ' ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014', ' crystallized nimodipine', 'Labeling: Label Mixup: VALSARTAN, Tablet, 160 mg may have potentially been mislabeled as one of the following drugs: PROGESTERONE, Capsule, 100 mg, NDC 00032170801, Pedigree: AD46320_1, EXP: 5/15/2014', 'Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing ', 'Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. ', 'Failed Dissolution Testing: Failed 24 month dissolution testing.', 'Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: BISACODYL EC, Tablet, 5 mg, NDC 00904792760, Pedigree: AD34931_1, EXP: 5/9/2014', 'Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.', 'CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.', ' product packaged with outdated version of the insert', 'Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD25452_10, EXP: 4/30/2014', ' METOPROLOL TARTRATE, Tablet, 25 mg, NDC 00378001801, Pedigree: W002535, EXP: 6/3/2014', 'Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.', \"Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.\", ' product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets', ' DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014', 'Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014', 'Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0', 'Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.', ' COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD30180_13, EXP: 5/9/2014', ' COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD37056_4, EXP: 5/10/2014. VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0, NDC 40985022251, Pedigree: AD7362', 'Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil', 'Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.', 'Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.', ' CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD52993_22, EXP: 5/20/2014. ', 'Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle', 'Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, NDC 58914001460, Pedigree: AD30180_10, EXP: 5/9/2014', 'Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.', 'Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage. ', 'Lack of Sterility Assurance', ' GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD60211_11, EXP: 5/22/2014.', ' potential for vial breakage', 'Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.', 'Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point. ', ' OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.', ' VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013', ' AT', 'Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003469, EXP: 6/20/2014. ', ' CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014', ' MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014', \"Non-Sterility: The firm's contract testing laboratory found sterility failures.\", ' After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.', 'Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: PHENobarbital, Tablet, 64.8 mg, NDC 00603516721, Pedigree: AD73518_7, EXP: 5/31/2014. ', 'Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein ', ' report of oversized and discolored tablets', 'Failed Stability Specifications: this product is below specification for preservative content.', 'Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.', 'Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL', 'Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.', ' product viscosity and or pH are below specification.', ' desmethyl carbondenafil and dapoxetine.', 'Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.', 'Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.', 'Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.', 'Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.', ' ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014', 'Presence of Particulate Matter: identified as cardboard.', ' MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG (1/2 of 25 MG), NDC 47335090288, Pedigree: AD21790_79, EXP: 5/1/2014', 'Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: AD28349_1, EXP: 2/28/2014', 'Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.', 'Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result. ', 'Penicillin Cross Contamination', 'Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.', ' increased complaints received for leaks', 'Failed Dissolution Specifications: Out-of-specification results in retained sample.', ' SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014. ', 'Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as one of the following drugs: guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD21790_58, EXP: 5/1/2014', 'Marketed Without an Approved ANDA/NDA: presence of sildenafil', 'Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.', 'Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.', 'Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.', ' IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ', 'Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 through 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.', 'Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD46312_22, EXP: 4/30/2014. ', ' buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.', ' impurity identified as cetirizine monosaccharide ester', 'Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 125 mcg may have potentially been mislabeled as the following drug: MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD70615_1, EXP: 2/28/2014. ', 'Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.', ' FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014', ' potential exposure to non-sterile lubricant during the filling process', 'Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. ', ' LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 16729018201, Pedigree: AD46414_25, EXP: 5/16/2014.', 'Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.', ' LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216', ' HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: W003438, EXP:', ' LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014. ', 'Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.', ' metal embedded in the glass vial and visible particles floating in the solution', ' ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014', 'Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.', ' HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003000, EXP: 6/11/2014. ', ' CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014. ', 'Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.', 'Defective Delivery System: Product may contain leaking capsules.', 'Labeling: Illegible label. Writing is rubbing off of labels.', 'Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. ', 'Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. ', 'CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.', 'Presence of Particulate Matter: Found during examination of retention samples.', 'The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ', 'Labeling: Label Mixup: CHOLECALCIFEROL, Capsule, 2000 units may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE HYCLATE, Tablet, 100 mg, NDC 53489012002, Pedigree: AD30993_8, EXP: 5/9/2014', 'Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. ', 'Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.', 'Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot', 'Failed Impurity/Degradation Specifications', 'Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.', 'Failed impurities/degradation specifications', 'Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.', ' CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014. ', ' methylPREDNISolone Tablet, 4 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00781519192, Pedigree: AD22616_10, EXP: 5/2/2014.', 'Subpotent Drug: Out of specification result for pramoxine hydrochloride', ' MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014. ', 'Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD21790_67, EXP: 5/1/2014. ', 'Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.', 'Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required \"C-IV\" imprint on the label for products distributed after the 06/11/12 deadline.', 'Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30028_34, EXP: 5/7/2014', ' MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141509, Pedigree: W003693, EXP: 4/30/2014. ', 'Microbial Contamination of Non Sterile Product', 'Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 100 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_7, EXP: 5/24/2014. ', ' RIVAROXABAN, Tablet, 20 mg,', ' SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014', ' CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD32757_53, EXP: 5/14/2014', 'Labeling: Label Mixup:predniSONE, Tablet, 20 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD54587_7, EXP: 5/21/2014.', 'Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..', ' 12 month time point for the active ingredient Phenylephrine HCl.', 'Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC 53191036201, Pedigree: AD60268_4, EXP: 5/22/2014', 'Labeling: Label Mixup: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD46426_22, EXP: 5/15/2014. ', ' Cetylpyridinum Chloride', 'Labeling Illegible: Missing Label', 'CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.', 'Presence of Particulate Matter', 'Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W003924, EXP: 6/28/2014. ', 'Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.', ' NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_10, EXP: 9/23/2013', 'Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe. ', 'Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.', 'Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage. ', ' ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014', 'Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.', ' LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 42794001802, Pedigree: AD46414_38, EXP: 5/16/2014. ', ' DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD52778_4, EXP: 5/20/2014. ', 'This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.', 'CGMP Deviation: Discoloration', 'CGMP Deviation: Poor container closure of the bulk storage container ', 'Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. ', ' TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD70625_1, EXP: 5/29/2014. ', 'Presence of Particulate Matter: particulate matter identified as glass in one vial. ', 'Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point. ', ' Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. ', ' HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: AD21790_16, EXP: 5/1/2014. ', 'Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution', ' guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD21790_52, EXP: 5/1/2014', ' product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug. ', ' MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially mislabeled as FLUVASTATIN, Capsule, 20 mg, NDC 00378802077, Pedigree: W002655, EXP: 6/4/2014.', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD60240_1, EXP: 5/22/2014. ', 'Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample ', ' DOCUSATE SODIUM, Capsule, 250 mg, ', ' Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag', ' TACROLIMUS, ', ' Product is being recalled because the birth control packs were distributed with out-dated package inserts. ', 'Tablet Separation: Possibility of cracked or split coating on the tablets.', ' HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg, NDC 63304029601, Pedigree: AD70629_10, EXP: 5/29/2014', ' VITAMIN B ', ' CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002666, EXP: 6/5/2014. ', ' MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W003779, EXP: 6/26/2014', 'Presence of Particulate Matter: visible particles were identified floating in the primary container.', ' GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.', ' PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014', 'Labeling: Not Elsewhere Classified: Product is labeled \"Dye Free\" on front panel but contains Red Dye 40.', 'Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.', ' RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: W003680, EXP: 6/25/2014', 'Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.', 'Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013. ', 'Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.', 'Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014', ' during stability testing', 'Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.', 'CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. ', ' TORSEMIDE, Tablet, 10 mg, NDC 31722053001, ', 'Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.', 'Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.', ' The label on the immediate bottle is missing.', 'Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.', ' 6 month stability time point', ' Product contains broken tablets.', 'Crystallization: Presence of crystals of Nimodipine within the capsule solution.', ' diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W002775, EXP: 6/6/2014', 'Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository', 'Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.', ' guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014', 'Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.', 'Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.', ' particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.', ' Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer.', ' CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014. ', 'Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. ', 'Failed Impurities/Degradation Specifications.', ' high out of specification result for 23 transacetyl impurity at the 22 month stability time point', 'Failed Dissolution Specifications: Drug failed stage III dissolution testing.', ' 12-Month stability interval.', 'Labeling: Label Mixup: CLINDAMYCIN HCL, Capsule, 300 mg may have potentially been mislabeled as the following drug: MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD68019_7, EXP: 5/28/2014. ', 'Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.', 'Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.', 'Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine', 'Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.', ' QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014', ' FLUVASTATIN SODIUM, Capsule, 20 mg, NDC 00078017615, Pedigree: AD73597_7, EXP: 5/31/2014', ' product is being manufactured and distributed without a NDC number', 'Crystallization: Active pharmaceutical ingredient is precipitating in product solution.', 'Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.', 'Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq. ', \"Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets\", ' NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014', 'Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.', 'Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.', 'Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval. ', 'Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.', 'Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the following drugs: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, NDC 11523726503, Pedigree: AD70655_20, EXP: 5/29/2014', ' DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014', ' blue polyisoprene shavings found inside the bag port tubes', \"Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.\", 'Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured. ', 'Labeling: Label Mixup:PROGESTERONE, Capsule, 100 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD73623_10, EXP: 5/30/2014. ', ' ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: W003096, EXP: 6/13/2014. ', 'Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole. ', ' various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.', ' GALANTAMINE HBr ER, Capsule, 8 mg, NDC 10147089103, Pedigree: W003509, EXP: 6/21/2014', 'Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.', 'Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014', ' damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product', ' for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point', 'Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W002660, EXP: 6/5/2014. ', ' MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014', ' product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) ', ' 18 month time point', ' RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014', 'Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. ', 'Labeling: Label Mixup: MIDODRINE HCL, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: PIOGLITAZONE HCL, Tablet, 15 mg, NDC 00093204856, Pedigree: W003264, EXP: 6/17/2014.\\t', 'Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A', 'Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.', ' MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014', 'Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.', ' ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014', ' HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003679, EXP: 6/25/2014', ' DULoxetine HCl DR,', ' FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W002920, EXP: 6/10/2014. ', ' CALCIUM', 'Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.', ' LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014', ' LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014', ' microbial contamination identified as Bacillus circulans ', ' PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014', 'Non-Sterility: Confirmed customer complaint of product contaminated with mold.', 'Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.', 'Failed Tablet/Capsule Specifications', 'Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.', ' PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014. ', ' CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014', ' LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014', 'Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014', 'Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.', 'Lack of Assurance of Sterility: Due to potential for leaking bags. ', 'Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.', \"Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.\", 'Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.', 'Failed Impurities/Degradation Specification', ' due to leaking vials', 'Labeling: Incorrect or Missing Package Insert', ' ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002512, EXP: 6/3/2014. ', ' carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: AD60272_1, EXP: 5/22/2014.', 'Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.', ' PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014', ' Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer', ' CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD30180_22, EXP: ', ' DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD37063_4, EXP: 5/13/2014', ' for 17-BMP at the 9 and 18 month stability time point', \" the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags\", ' WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.', ' MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: AD46265_28, EXP: 5/15/2014', 'Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs', 'Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.', 'Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. ', 'Labeling: Label Mixup: VALSARTAN, Tablet, 320 mg may have potentially been mislabeled as the following drug: CILOSTAZOL, Tablet, 100 mg, NDC 60505252201, Pedigree: AD65475_4, EXP: 5/28/2014. ', ' METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003900, EXP: 6/27/2014', ' ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014', 'Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).', 'Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014', ' VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014. ', 'Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. ', 'Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 12.5 mg may have potentially been mislabeled as the following drug:, CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD52778_13, EXP: 5/20/2014. ', ' RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD21790_22, EXP: 5/1/2014', 'Failed Tablet/Capsule Specifications: Complaints of empty capsules received.', ' DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD52375_1, EXP: 5/17/2014', ' ISOSORBIDE MONONITRATE, Tablet, 10 mg, NDC 6217501060', 'Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.', ' CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014. ', 'Defective delivery system: detached needles on the syringe in the kit.', 'Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: ADWA00002146, EXP: 5/31/2014. ', ' testing revealed out of specification results for total aerobic microbiological count', ' VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014', 'Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.', 'Labeling: Label Mixup: DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD65323_1, EXP: 5/29/2014.', ' an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read \"If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.\" The labeling for the recalled lots ', ' 12 month stability testing.', ' Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.', ' MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W003923, EXP: 6/28/2014. ', ' Cartridges labeled to contain 1 mL found to contain 2.2 mL', ' PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD73521_25, EXP: 5/30/2014. ', 'Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics. ', ' ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: W003641, EXP: 6/25/2014. ', 'Labeling: Label Mixup: TERAZOSIN HCL, Capsule, 5 mg may have potentially been mislabeled as the following drug: DOXAZOSIN MESYLATE, Tablet, 1 mg, NDC 00093812001, Pedigree: W003912, EXP: 6/28/2014. ', \"Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.\", 'Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.', 'Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.', 'Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. ', ' Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte. ', 'Lack of Assurance of Sterility: Potential cracks in glass vials', ' COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014', ' PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010, Pedigree: AD52993_28, EXP: 5/20/2014.', ' HYDROCORTISONE, Tabl', ' MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD73521_10, EXP: 5/30/2014. ', ' CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), NDC 00143117101, Pedigree: AD46312_4, EXP: 5/16/2014', 'Non-Sterility: Out of specification results for the sterility test for microbial contamination.', 'Short Fill: some bottles contained less than 120-count per labeled claim.', ' LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014', ' Product may not meet specifications for color description once reconstituted.', 'Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: EFAVIRENZ, Capsule, 200 mg, NDC 00056047492, Pedigree: AD46312_31, EXP: 5/16/2014. ', ' LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014', ' foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine ', ' tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: W002663, EXP: 6/5/2014', 'Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.', 'Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.', 'Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.', ' LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014. ', 'Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.', 'Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.', ' glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: W003688, EXP: 5/31/2014', ' Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions', ' report of visible particulates in the glass ampule', ' VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD65457_22, EXP: 5/24/2014.', ' CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014', 'Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.', 'Labeling: Label Error on Declared Strength', 'Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.', ' LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg, NDC 00093312901, Pedigree: AD65323_4, EXP: 5/29/2014.', 'Labeling: Label Mix Up', ' ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.', 'CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.', ' CINACALCET HCL, Tablet, 30 mg, N', ' PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003229, EXP: 6/17/2014', ' leaks were observed from the bag seam and port seal', 'Microbial Contamination of Non-Sterile Product', 'Subpotent Drug: Low out-of-specification potency result of the drug product. ', ' CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W003075, EXP: 6/12/2014', ' metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD32742_1, EXP: 5/1/2014.', 'Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>. ', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003015, EXP: 6/12/2014', 'Failed Stability Specifications: product may not meet specification limit for assay test.', 'Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.', 'Products failed the Antimicrobial Effectiveness Test', ' ASPIRIN, CHEW Tablet, 81 mg, NDC 00536329736, Pedi', 'Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 500 mg, NDC 00904052380, Pedigree: AD54576_4, EXP: 5/20/2014. ', ' C', 'Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor. ', 'Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.', ' traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00527163801, Pedigree: AD60272_76, EXP: 5/22/2014.', ' ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014. ', 'Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.', 'Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.', 'Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.', ' traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP: 5/20/2014.', 'Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.', 'Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. ', 'Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00004025901, Pedigree: AD49414_1, EXP: 5/17/2014. ', 'Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.', 'Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.', 'Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch', 'CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.', 'Non-Sterility', 'Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.', ' METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD22845_1, EXP: 4/30/2014', 'Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth. ', ' 12-month stability time point', 'Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.', ' ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014', ' fluocinolone acetonide', 'Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.', 'Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.', ' PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD54498_1, EXP: 5/20/2014', ' NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: W003739, EXP: 6/26/2014', 'Non-Sterility: failed sterility test result.', 'Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg. ', 'Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.', 'Subpotent Drug: Flurandrenolide is subpotent.', ' DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD46312_7, EXP: 5/16/2014.', 'Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.', 'Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.', 'Customer complaints for failure to deliver the dose.', 'Labeling: Label Mixup: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: ADWA00002136, EXP: 5/31/2014.', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .', 'Labeling: Incorrect or Missing Lot and/or Exp. Date', ' GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014', 'Tablet/Capsule Imprinted with Wrong ID', 'Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.', 'Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101, Pedigree: AD22609_1, EXP: 5/2/2014.', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 ', ' GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003624, EXP: 1/31/2014.', 'Labeling: Label Mixup: ESTRADIOL, Tablet, 0.5 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, GUM, 2 mg, NDC 00536302923, Pedigree: AD33897_28, EXP: 2/28/2014. ', 'Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.', ' METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 576640', 'Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014.', ' Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014', 'Failed Impurities/Degradation Specifications: OOS results for known compound.', 'Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.', ' QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree: AD32325_1, EXP: 5/9/2014', ' guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014. ', ' This recall is being initiated because the lot number and expiration date on the tube may not be legible.', ' guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014', 'Labeling: Label Mixup: VERAPAMIL HCL ER, Capsule, 240 mg may have potentially been mislabeled as the following drug: FEBUXOSTAT, Tablet, 40 mg, NDC 64764091830, Pedigree: W002664, EXP: 6/5/2014.', ' MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014', ' DOXYCYCLINE HYCLATE, Tablet, 100 mg may be potentially mislabeled as DESLORATADINE, Tablet, 5 mg, NDC 00085126401, Pedigree: AD30993_5, EXP: 2/28/2014.', 'Non-Sterility: The recalled lot failed sterility testing.', \"Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.\", 'Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.', 'Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes..', 'Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. ', 'Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile. ', 'Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.', 'Cross contamination with other products: metronidazole', 'Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.', 'Defective Delivery System', 'Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.', ' clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46265_25, EXP: 5/15/2014', 'CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.', ' QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP: 6/24/2014.', ' LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD73525_49, EXP: 5/30/2014. ', 'Labeling: Label Mixup: ANAGRELIDE HCL, Capsule, 0.5 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46414_1, EXP: 5/16/2014.', ' The identification codes on some tablets may be unreadable', ' PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014. ', 'Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch. ', ' product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg', 'Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.', ' preservative may not have dissolved completely or precipitated out of product', ' bupivacaine', 'Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.', 'Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.', 'Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug. ', 'Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.', ' glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014', ' CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014. ', 'Labeling: Incorrect Instructions', 'Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.', 'Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)', 'Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating \"Do cut the patch\" rather than the correct instructions of \"Do not cut the patch\". The pouch containing the patch is labeled correctly. ', 'Subpotent Drug: failed at the 3 and 6 month stability time points.', 'Microbial contamination of Non-Sterile Products', 'Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ', 'Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.', 'Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.', 'Lack of Assurance of Sterility: Sterility of product is not assured', ' CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014', ' single visible particulate was identified during a retain sample inspection identified as stainless steel', 'Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabeled as the following drug: predniSONE, Tablet, 20 mg, NDC 00591544301, Pedigree: AD56879_5, EXP: 5/21/2014. ', 'Chemical contamination: emission of strong odor after package was opened', ' COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: AD46265_31, EXP: 5/15/2014.', 'Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating \"use for the cure of most jock itch\" rather than \"use for the cure of most athlete\\'s foot\".', ' aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014', 'Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. ', ' VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014. ', 'CGMP Deviations: Shipment of product not approved for release.', ' Product contains unapproved hHCG.', 'Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.', ' PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014', 'Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 100 mg may have potentially been mislabeled as the following drug: PROGESTERONE, Capsule, 100 mg, NDC 00591396401, Pedigree: AD73611_4, EXP: 5/30/2014. ', 'Microbial Contamination of Non-Sterile Products: Failed S.aureus test.', 'cGMP Deviations', 'Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.', 'Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.', ' ZINC SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52778_10, EXP: 5/20/2014', ' Dry mix failed blend uniformity.', 'Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014', 'Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials. ', 'Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.', 'Presence of Particulate Matter: particulate matter identified as an insect in one vial.', 'Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.', 'Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.', 'Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.', 'Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.', 'Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production. ', 'Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.', ' NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014', 'Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag', ' BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: AD52993_34, EXP: 5/20/2014.', 'Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).', \"Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. \", 'Failed Dissolution Specifications: out of specification dissolution results in retained samples ', ' ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W003731, EXP: 6/26/2014.', 'Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD76675_1, EXP: 6/3/2014.', 'Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.', 'Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.', 'Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544', 'Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.', 'Falied pH specification', 'Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.', 'Presence of Particulate Matter: Glass particles found in the product after reconstitution.', ' IBUPROFEN, Tablet, 400 mg may be potentially mislabeled as ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W002573, EXP: 6/3/2014.', ' PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014. ', ' CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014. ', ' Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.', 'Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.', 'Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured. ', 'cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. ', 'Labeling: Label Mixup: ESTROPIPATE, Tablet, 0.75 mg may have potentially been mislabeled as the following drug: MESALAMINE DR, Capsule, 400 mg, NDC 00430075327, Pedigree: AD34934_1, EXP: 1/31/2014.', ' GALANTAMINE HBr ER, Capsule, 8 mg may be potentially mislabeled as FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003508, EXP: 6/21/2014.', 'Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.', ' PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD70639_10, EXP: 5/29/2014. ', 'Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014', 'Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..', ' Pedigree: W002656, EXP: 6/4/2014. ', 'Labeling: Label Mixup: SIMVASTATIN, Tablet, 5 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 13668011390, Pedigree: AD65323_10, EXP: 5/29/2014. ', ' PIROXICAM, Capsule, 10 mg, NDC 00093075601, Pedigree: AD21836_1, EXP: 3/31/2014. ', 'Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.', ' PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.', ' Immediate product pouches may not be properly sealed.', 'Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.', 'Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets', 'Subpotent Drug: concentration of product is less than labeled amount. ', 'Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. ', 'Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).', 'Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.', 'Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label', ' outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%', ' Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. ', 'Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.', 'Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.', 'Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. ', ' at the 6-month stability time point', ' product description section of testosterone cypionate incorrectly states \"in grapeseed oil\" instead of \"in sesame oil\" . The primary panel is correct', 'Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval', 'Labeling: Label Mixup: azaTHIOprine, Tablet, 50 mg may have potentially been mislabeled as the following drug: SELENIUM, Tablet, 50 mcg, NDC 00904316260, Pedigree: AD56939_1, EXP: 5/21/2014. ', 'CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.', ' HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.', ' equipment failure led to potential breach in asceptic process.', 'Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the following drugs: HYDROCORTISONE, Tablet, 5 mg, NDC00603389919, Pedigree: AD60272_13, EXP: 5/22/2014', ' FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.', 'Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. ', 'Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.', 'Subpotent. drug', 'Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.', 'Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. ', ' bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL', 'Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.', ' Some bottles of product were missing the color-coded strength on the primary display panel of the label.', 'Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014', 'Failed Content Uniformity Specifications', 'Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014.', 'Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. ', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014', 'Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.', ' guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014', 'Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.', ' TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014', ' ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003101, EXP: 6/13/2014', 'Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003787, EXP: 6/27/2014', 'Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.', 'Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.', 'Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug. ', 'Lack of Assurance of Sterility: Sterility of product is not assure', ' DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: W003247, EXP: 6/17/2014. ', 'Presence of Particulate Matter: identified as a cloth fiber.', ' DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014', ' clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014', ' label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.', 'Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.', ' PRO', 'Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.', 'Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. ', 'Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.', ' PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.', ' clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00093083201, Pedigree: AD73518_1, EXP: 5/31/2014', 'Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. ', ' VALSARTAN, Tablet, 160 mg, NDC 0007803', 'Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.', 'Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.', ' prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013.', 'Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.', 'Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg, NDC 59762500001, Pedigree: AD46265_13, EXP: 5/15/2014', ' microbial assay reported unacceptable high plate counts and positive for E. Coli', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003870, EXP: 6/27/2014. ', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine', ' CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium may be potentially mislabeled as TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201, Pedigree: AD28333_4, EXP: 5/6/2014.', 'Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.', ' CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: W003730, EXP: 6/26/2014', ' product may contain fibrous material', 'Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.', 'Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin', ' hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014', \"Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.\", 'Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.', 'Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.', 'Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.', ' ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.', 'Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.', ' PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.', 'Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.', 'Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.', 'Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD46426_1, EXP: 5/15/2014. ', ' potential for charcoal particulates', ' potential that a low level of endotoxins may be present in the diluent vials.', ' Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. ', 'Labeling: Label Mixup:quiNIDine SULFATE, Tablet, 200 mg may have potentially been mislabeled as the following drug: QUINAPRIL, Tablet, 40 mg, NDC 31722027090, Pedigree: AD52778_76, EXP: 5/21/2014. ', 'Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. ', 'Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.', 'Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel', ' CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014.', 'Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.', 'Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD46419_1, EXP: 5/16/2014', 'Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..', 'Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.', ' CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014', ' Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).', ' traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014', ' SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: W002974, EXP: 6/11/2014.', \"Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.\", 'Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point. ', 'Presence of Particulates', 'Cross Contamination with Other Products: Product contains Promacta (eltrombopag).', 'Marketed Without An Approved NDA/ANDA ', 'Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.', ' some patches may not contain fentanyl gel ', ' lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot', ' CALCIUM POLYCARBOPHIL, Tablet, 625 mg, NDC 00536430611, Pedigree: AD73592_11, EXP: 5/31/2014. ', 'Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. ', \"Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.\", ' LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014', ' MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500', 'Failed Tablet/Capsule Specifications: out of specification for thickness.', 'Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.', 'Presence of Foreign Tablets/Capsules', 'Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. ', ' PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD65457_4, EXP: 5/24/2014. ', 'Lack of assurance of sterility ', ' aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014', ' MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, 0, ND', 'Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.', 'Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. ', 'Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.', 'Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD46265_34, EXP: 5/15/2014', 'Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD73611_1, EXP: 5/30/2014', 'GMP Deviations', 'Presence of Particulate Matter: particulate matter identified as fibers and/or plastics', ' leaking of premix bags ', 'Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.', 'Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.', 'Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.', ' PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014', ' metal particulates were visually observed in the tablets.', 'Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003707, EXP: 6/25/2014. ', 'Defective delivery system: Softgel capsules are leaking.', ' SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014', 'Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014', 'Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.', ' CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD49463_1, EXP: 5/16/2014', ' mold contamination', 'Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.', 'Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.', 'Failed Impurities/Degradation Specifications: Out of specification for impurities.', 'Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.', ' QUINAPRIL Tablet, 40 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 16714002104, Pedigree: AD52778_73, EXP: 5/21/2014.', ' 8-hours for the 18-month stability testing point.', ' ARIPiprazole, Tablet, 15 mg may be potentially mislabeled as ATOMOXETINE HCL, Capsule, 40 mg, NDC 00002322930, Pedigree: AD21790_82, EXP: 5/1/2014', 'Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by ', ' TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014', ' LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014', 'Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014', 'Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. ', 'Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with. ', ' FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 60505251002, Pedigree: AD46414_19, EXP: 5/16/2014', ' benzocaine', ' 12 month stability timepoint', 'Labeling: Label Mixup: DESMOPRESSIN ACETATE, Tablet 0.1 mg may have potentially been mislabeled as the following drug: LOXAPINE, Capsule, 5 mg, NDC 00591036901, Pedigree: AD46426_7, EXP: 5/15/2014. ', ' 8 hr stability timepoint', ' LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68028_1, EXP: 5/28/2014', 'Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.', 'Labeling: Incorrect or Missing Lot and/or Expiration date', 'Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.', ' all sterile human compounded drugs within expiry', ' presence of black particles describes generically as cellulose-based bundles of brown fibrous material. ', ' CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014', 'Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD56924_1, EXP: 5/21/2014', 'Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.', ' product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg', ' ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014', ' medication was sterilized with a recalled filter', ' some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.', 'Labeling: Label Mixup: amLODIPine BESYLATE, Tablet, 5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W002839, EXP: 6/7/2014. ', ' CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003828, EXP: 6/', 'Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials', 'Marketed without an Approved NDA/ANDA.', ' HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6', ' MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014', 'Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.', ' LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD60272_25, EXP: 5/22/2014', ' Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life ', 'Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.', ' contaminated with Klebsiella pneumoniae', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: AD73611_7, EXP: 5/30/2014', ' METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003844, EXP: 6/27/2014', ' NIACIN TR, Capsule, 500 mg, N', ' SODIUM CHLORIDE, Tablet, 1000 mg, NDC 00527111610, Pedigree: W003926, EXP: 7/1/2014. ', 'Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.', ' SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014. ', 'Labeling: Label Mix-Up', 'Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014', 'Sub-potent Drug', ' at the 18 month time point. ', ' CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014', ' CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD52778_61, EXP: 5/20/2014', 'Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD73627_29, EXP: 5/30/2014', 'Labeling: Label Mixup: HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg may have potentially been mislabeled as one of the following drugs: hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD73652_4, EXP: 5/29/2014', 'Labeling: Label Mixup: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg may have potentially been mislabeled as one of the following drugs: SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD39858_4, EXP: 5/15/2014', ' amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: AD62846_1, EXP: 2/28/2014.', 'Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..', 'Failed Impurities/Degradation Specifications', ' QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014', ' NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014', ' guaiFENesin ER, Table', ' PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003704, EXP: 6/26/2014.', ' FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014', 'Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.', 'Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.', ' MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W002712, EXP: 6/6/2014', 'Subpotent Drug: Drug potency was compromised during shipment.', ' trailer may not have met GMP requirements prior to filling', ' chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70629_4, EXP: 5/29/2014', 'Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. ', 'Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.', 'Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. ', 'Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.', 'PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect. ', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014. ', ' DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD60211_8, EXP: 5/21/2014', ' Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.', 'Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.', 'Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.', 'Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler', ' chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014', 'Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.', 'Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.', ' VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014. ', 'Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.', ' labeled with incorrect EXP Date', ' MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013.', 'Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.', 'Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014', ' WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.', ' BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD37056_13, EXP: 5/10/2014.', 'Non Sterility: Microbial contamination ', 'Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets. ', 'Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014. ', 'Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.', ' diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014', ' LIOTHYRONINE SODIUM,', ' MYCOPHENOLATE MOFETIL, Tablet, 500 mg, NDC 00004026001, Pedigree: AD49414_4, EXP: 5/17/2014', 'Failed Stability Specification', ' hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014', 'Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. ', ' FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014.', 'Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.', 'Labeling: Label Mixup: VERAPAMIL HCL, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W003095, EXP: 6/12/2014', 'Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.', 'Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.', 'Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.', 'Lack of Assurance of Sterility: Complaints of broken tips on the ampules.', ' It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.', 'Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. ', 'Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.', 'Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.', 'Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.', 'Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.', 'Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD70639_1, EXP: 5/29/2014', ' Senna Leaf powder 140 mg. It should correctly be stated as &quot', 'Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..', 'Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.', 'Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.', ' 9 month stability', 'Discoloration: presence of scuffing marks on tablets. ', 'Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.', ' ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.', 'Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.', 'Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.', 'Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. ', ' FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin ', 'cGMP deviations - presence of rubber particles found loose in the bulk product.', 'Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.', 'Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry. ', 'Lack of assurance of sterility: Potential channel leaks near the threaded vial port.', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein', ' LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014. ', 'Marketed Without an Approved NDA/ANDA: The products are unapproved drugs', ' LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: W002652, EXP: 6/5/2014', 'Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.', ' laboratory testing was not followed in accordance with GMP requirements.', 'Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.', 'Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: MIDODRINE HCL, Tablet, 2.5 mg, NDC 00185004001, Pedigree: W003265, EXP: 6/17/2014. ', 'Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the \"Clinical Studies\" and \"Specific Adverse Events\" sections.', 'Subpotent Drug: trace amounts of methylcobalamin in compounded drug.', 'Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of \\x1cPreservative free\\x1d on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative. ', 'Failed Dissolution Specifications ', 'Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.', ' RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.', ' however it should state 2mg per mL', 'Failed Dissolution Test Requirements', 'Subpotent Drug: Subpotent atorvastatin.', 'Subpotent drug. ', 'Cross Contamination with Other Products: Product was mixed with another type of mouth wash. ', 'Failed Impurity/degradation Specification', ' FDA analysis found them to contain sibutramine and phenolphthalein', ' MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD62865_13, EXP: 5/23/2014', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013. ', ' AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: AD21790_1, EXP: 5/1/2014. ', ' PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 009045', 'Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one of the following drugs: sitaGLIPtin PHOSPHATE, Tablet, 50 mg, NDC 00006011231, Pedigree: W002824, EXP: 6/7/2014', ' The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.', 'Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.', 'Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788, EXP: 6/27/2014', ' ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, NDC 46122010478, Pedigree: W003722, EXP: 4/30/2014', ' DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014', 'Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .', 'Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.', ' RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree: AD21787_4, EXP: 5/1/2014', ' glyBURIDE MICRONIZED, Tablet, 3 mg, NDC 00093803501, Pedigree: W003155, EXP: 6/13/2014. ', 'Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.', 'Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the following drug: metFORMIN HCl, Tablet\\t500 mg, NDC 23155010201, Pedigree: AD46312_25, EXP: 5/16/2014. ', 'Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside. ', ' SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014', 'Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.', ' TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD37056_1, EXP: 5/10/2014', 'Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.', ' CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014', 'CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.', ' ACARBOSE, Tablet, 25 mg', ' PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD46257_25, EXP: 5/15/2014', 'Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.', 'Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).', \"Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.\", ' ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD39588_4, EXP: 5/13/2014.', ' guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD30140_37, EXP: 5/7/2014', 'Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. ', 'Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.', 'Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility. ', 'CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. ', ' 36 month stability timepoint', 'Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.', 'Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.', ' NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003361, EXP: 6/19/2014.', ' TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7', 'Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014', ' DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W003821, EXP: 6/27/2014', 'Labeling: Label Mix Up- Incorrect back label applied to the product.', 'Defective container: products are packaged in pouches which may not have been fully sealed', ' OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: W003898, EXP: 6/27/2014. ', 'Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014', 'Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.', ' PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, NDC 13668009190, Pedigree: AD25264_10, EXP: 5/3/2014. ', 'Labeling: Label Mixup: PERPHENAZINE, Tablet, 8 mg may have potentially been mislabeled as the following drug: NIFEdipine, Capsule, 10 mg, NDC 59762100401, Pedigree: AD52778_55, EXP: 5/20/2014. ', 'Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.', 'Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak. ', 'Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.', 'Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.', ' CYPROHEPTADINE HCL Tablet, 4 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W003673, EXP: 6/25/2014', ' SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree: W003754, EXP: 6/26/2014.', 'CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.', ' SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014. ', 'Labeling: Label Mixup: THIORIDAZINE HCL, Tablet, 50 mg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD73525_13, EXP: 4/30/2014.', ' NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 37205098769, Pedigree: AD73623_7, EXP: 5/30/2014', 'Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules. ', 'Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014', ' NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.', ' COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W003871, EXP: 6/27/2014', 'Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.', 'Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.', 'Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003713, EXP: 6/26/2014', 'Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.', 'Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone. ', ' The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP. ', 'CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ', 'Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.', 'Superpotent Drug: Out Of Specification (OOS) result for Assay.', 'CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. ', 'Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.', 'Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.', ' PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00904531360, Pedigree: W003706, EXP: 6/25/2014', ' MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: W003691, EXP: 6/26/2014.', 'Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.', ' ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014', ' HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014', ' carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, EXP: 6/18/2014. ', 'Labeling: Label Mixup: VITAMIN B COMPLEX, Capsule, 0 mg may have potentially been mislabeled as the following drug: ACARBOSE, Tablet, 25 mg, NDC 23155014701, Pedigree: AD32757_1, EXP: 5/13/2014. ', 'Labeling: Label Error On Declared Strength', 'Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.', 'Chemical Contamination: Bottles may contain broken dessicants', 'Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..', 'Labeling: Not Elsewhere Classified', 'Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potentially mis-labeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: AD52387_1, EXP: 5/17/2014. ', 'Presence of Precipitate', ' and a missing stopper and flip cap were received and therefore sterility cannot be assured.', ' PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011010, Pedigree: AD65317_1, EXP: 5/24/2014. ', ' The Lot and/or Expiration date on the tube may not be legible in this lot.', ' ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W003355, EXP: 6/19/2014', 'Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.', ' 9-month stability interval', ' product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes', ' Hydrochlorothiazide at the 9 month time point.', ' LACTOBACILLUS GG, Capsule, 0 mg, NDC 49100036374, Pedigree: W003173, EXP: 6/13/2014. ', ' MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.', ' Out of specification results for two known degradation products and total impurities at 18 months', 'Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014. ', ' out of specification results for heparin raw material', ' LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD21965_22, EXP: 5/1/2014.', 'Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.', 'Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.', ' ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: AD33897_1, EXP: 5/9/2014', ' PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD30140_31, EXP: 5/7/2014.', 'Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.', ' ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.', 'CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.', 'Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: AD70700_10, EXP: 5/29/2014.', 'Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.', 'Failed Impurity/Degradations Specifications', ' LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014', 'Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.', 'Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.', 'Labeling: Label Mixup: ASPIRIN, CHEW Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_4, EXP: 5/8/2014', ' box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014. ', 'Superpotent Drug: Product may not meet specifications throughout shelf life. ', 'Lack of Assurance of Sterility: Sterility of product is not assured.', ' sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.', 'Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation. ', 'Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial. ', ' THIORIDAZINE HCL, Tablet, 50 mg, NDC 00378061601, Pedigree: AD73525_28, EXP: 5/30/2014. ', 'Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states &quot', 'Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. ', 'Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.', 'Lack of Processing Controls', ' CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: W003638, EXP: 6/25/2014. ', ' does not meet in process specification requirements', 'Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD54516_4, EXP: 5/20/2014.', 'Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.', 'CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices', 'Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.', ' FLUoxetine HCl, Capsule, 10 mg\\t, NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014', 'Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014', 'Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.', ' MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.', ' REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD70639_13, EXP: 5/29/2014', ' small number of tubes may include the presence of mold on the cap', 'Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD46429_1, EXP: 5/15/2014.', ' TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014', 'Failed tablet/capsule specification: missing break line on the 5mg tablet.', 'Defective Container', ' TORSEMIDE, Tablet, 10 mg, NDC 31722053001,', 'Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules', 'Failed Tablet/Capsule Specification', ' All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. ', 'Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014. ', ' buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014', 'Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD73521_13, EXP: 5/30/2014. ', 'Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.', ' exceeded specification at the 9 hour time point', 'CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.', 'Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).', ' PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014', ' Lozenges are overly thick, overly soft, and sub and superpotent.', ' ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: W002973, EXP: 6/11/2014', ' PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree', 'Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.', 'Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.', 'CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.', 'Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.', 'Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.', ' FDA inspection revealed poor aseptic practices and conditions potentially affecting the sterility of their compounded sterile products', 'Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014. ', 'Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.', 'Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules. ', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014. ', 'Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.', ' ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD49582_7, EXP: 5/16/2014. ', ' GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD73525_4, EXP: 5/30/2014.', ' out of specification results for carbon dioxide', ' CHOLECALCIFEROL', ' identified as calcium salt of Ketorolac ', 'Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life', 'Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD49399_4, EXP: 5/16/2014', ' QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP: 5/14/2014.', ' Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder', 'Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.', 'Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. ', 'Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.', \"Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.\", ' CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014', 'Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.', 'Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.', ' P', 'Lack of Assurance of Sterility: Sterility of product is not assured. ', 'Presence of Particulate', ' RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD32757_47, EXP: 5/13/2014', ' an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing ', ' precipitation of drug product', ' ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014. ', 'Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.', ' guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014', ' rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.', ' tablets may contain stainless steel metal particulates ', ' LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 4092025290, Pedigree: W003410, EXP: 6/19/2014. ', 'CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.', 'Defective Container: There were customer complaints of cracked and leaking glass vials.', 'Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.', ' reports of damaged product that may alter the predicted release of scopolamine following transdermal application.', 'Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.', 'Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.', 'Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.', 'Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, EXP: 5/20/2014. ', 'Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol', ' lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume', ' PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PIOGLITAZONE HCL, Tablet, 15 mg, NDC 00093204856, Pedigree: AD52778_70, EXP: 5/21/2014.', 'Lack of Sterility Assurance.', 'Labeling: Incorrect Package Insert', 'Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.', ' bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets ', 'Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD21790_28, EXP: 5/1/2014', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014', \"Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.\", ' possible loose crimp applied to fliptop vial', ' OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: AD32757_40, EXP: 5/14/2014', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine', 'Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. ', 'Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.', 'Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.', 'Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug. ', 'Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point. ', ' FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: W003031, EXP: 2/28/2014. ', 'Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.', 'Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: W003649, EXP: 6/25/2014.', 'Labeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled as the following drug: ERYTHROMYCIN DR EC, Tablet, 250 mg, NDC 24338012213, Pedigree: AD46426_13, EXP: 5/15/2014.', ' GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601', ' COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD70655_11, EXP: 5/28/2014', ' CHOLECALCIFEROL, Tablet', 'Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.', ' guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014', 'Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.', ' MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium) may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD30197_7, EXP: 5/9/2014.', 'Subpotent Drug.', 'Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing', 'Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 50 mg may have potentially been mislabeled as the following drug: ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD32973_1, EXP: 5/9/2014. ', 'Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. ', ' CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014', 'Labeling: Not elsewhere classified. NDC number is incorrect on the container. ', ' MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as PRENATAL MULTIVITAMIN/MULTIMINERAL Tablet, NDC 00904531360, Pedigree: AD73652_16, EXP: 5/30/2014.', ' reports of adverse events after injection', 'CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ', \"CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.\", ' Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.\\x1d ', ' Product was found to be contaminated with Sphingomonas paucimobilis bacteria.', ' ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: W003687, EXP: 6/26/2014', 'Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. ', 'Labeling: Label Mixup: THIAMINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 5 mg, NDC 00093715298, Pedigree: AD65323_13, EXP: 5/29/2014', ' this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug', ' out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.', ' carBAMazepine ER, Tablet, 100 m', 'Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.', 'Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.', 'Impurities/Degradation Products', ' no identity or purity testing on incoming oxygen gas, and lack of documentation', ' CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002693, EXP: 6/5/2014', ' ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.', ' incorrect or missing insert', 'Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.', 'Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.', ' partial tablet erosion resulting in tablet weights below specification in some tablets', 'Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD30024_1, EXP: 5/9/2014', 'Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.', 'Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. ', 'Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 60505267109, Pedigree: AD21965_4, EXP: 5/1/2014. ', ' glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014', 'Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium ', 'Subpotent Drug: out of specification results for assay test.', ' MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD60240_14, EXP: 5/22/2014', ' contract laboratory identified Staphylococcus warneri in the product', ' FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: W002733, EXP: 6/6/2014', 'Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014. ', 'Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.', ' GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESCITALOPRAM, Tablet, 5 mg, NDC 00093585001, Pedigree: W003733, EXP: 6/26/2014.', 'Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER\\t, Tablet, 500 mg, NDC 61958100301, Pedigree: AD62995_7, EXP: 5/29/2014', ' VITAMIN B COMPLEX ', ' FDA inspection revealed poor aseptic practices and conditions potentially affecting the sterility of their compounded sterile products.', ' heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing. ', 'Presence of foreign substance: One lot of the product may contain black foreign particles ', ' Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.', 'Presence of Particulate Matter: identified as dried skin.', ' due to prolonged heat exposure.', ' SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014', ' PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014', ' lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014', 'Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing. ', ' VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0 mg, NDC 40985022251, Pedigree: AD76686_1, EXP: 5/31/201', ' ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD28322_1, EXP: 5/6/2014. ', ' manufacturer is Not Registered with the Food and Drug Administration', 'Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. ', 'Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).', 'Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.', 'Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet. ', 'Failed Stability Specifications: Out of specification result for preservative sodium benzoate.', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD60272_19, EXP: 5/22/2014. ', 'Labeling: Label lacks warning or Rx legend', ' glyBURIDE, Tablet, 2.5 mg, NDC 0009383', ' carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.', ' tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP: 4/30/2014', 'Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. ', 'Tablets/Capsules Imprinted with Wrong ID', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003705, EXP: 6/25/2014', 'Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.', ' NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.', 'Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. ', ' ATORVASTATIN CALCIUM, Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, 10 Billion Cells, NDC 49100036374, Pedigree: AD21965_19, EXP: 5/1/2014.', ' Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.', 'CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.', ' LETROZOLE Tablet, 2.5 mg may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003848, EXP: 6/27/2014.', 'Subpotent Drug: Salicylic acid is subpotent.', 'Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.', ' objectionable conditions observed during a FDA inspection ', ' VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD30180_16, EXP: 5/9/2014', ' VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014. ', ' HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014', 'Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.', 'Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014. ', 'Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.', 'GMP deviation', ' product not manufactured under sterile conditions as required for ophthalmic drug products', 'Labeling: Incorrect Expiration Date', ' correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP', ' ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014', ' MULTIVITAMIN/MULTIMINERAL Chew Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD30140_40, EXP: 5/7/2014', 'Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug. ', 'Failed Dissolution Specifications: Failed 24 month dissolution testing.', ' LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014', ' ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014', ' PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP: 6/18/2014', \" firm's analysis revealed subpotent result for morphine sulfate assay.\", 'Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).', ' tablet breakage while pushing through the blister pack (dispenser) .', ' product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL', ' BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.', 'Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the following drug:\\t FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD49448_4, EXP: 5/17/2014. ', ' CRANBERRY Tablet, 450 mg may be potentially mislabeled as METOPROLOL SUCCINATE ER, Tablet, 200 mg, NDC 62037083301, Pedigree: AD73652_13, EXP: 5/30/2014.', ' tablets may contain stainless steel metal particulates', ' amLODIPine BESYLATE, Tablet, 5 mg, NDC 00093716798, Pedigree: W002840, EXP: 6/7/2014. ', 'Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life. ', 'Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.', 'Lack of sterility assurance.', ' guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014', 'Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj. ', ' tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.', 'Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits. ', 'Failed Impurities/Degradation Specifications: unspecified degradation product', ' LACTASE ENZYME Tablet, 3000 units may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: AD21811_4, EXP: 5/1/2014', 'Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.', ' out of specification result for particle size distribution during stability testing', 'Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..', 'Lack of Assurance of Sterility: Product sterility cannot be guaranteed.', 'Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.', ' PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: W003257, EXP: 6/17/2014. ', ' CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: W002653, EXP: 6/5/2014', ' MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule may be potentially mislabeled as CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD21846_37, EXP: 5/1/2014', 'Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.', 'Labeling: Label Mixup: MODAFINIL, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003692, EXP: 6/26/2014. ', 'Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.', 'Labeling: Label Mixup: TERBUTALINE SULFATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug:\\t SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD52778_85, EXP: 5/21/2014. ', ' PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: AD60264_1, EXP: 5/22/2014', 'Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.', 'Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.', 'Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.', ' mold', 'Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.', ' PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014. ', 'Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.', 'Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.', 'Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: traMADol HCl, Tablet, 25 mg (1/2 of 50 mg), NDC 57664037708, Pedigree: AD60272_92, EXP: 5/22/2014. ', 'Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.', 'Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.', 'Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.', ' ASPIRIN, Tab', 'Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.', 'Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.', 'Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.', ' Complaints that cream appears to have crystallized', 'Labeling: Label Mixup: IRBESARTAN, Tablet, 150 mg may have potentially been mislabeled as the following drug: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD32757_7, EXP: 5/13/2014. ', 'Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.', ' product found to contain undeclared sibutramine', 'Labeling: Label Mixup: METHOCARBAMOL, Tablet, 500 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 00093736498, Pedigree: AD46312_16, EXP: 5/16/2014.', 'Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.', 'Labeling: Label Mixup: PIROXICAM, Capsule, 10 mg may have potentially been mislabeled as the following drug: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD30140_10, EXP: 5/7/2014. ', 'Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.', 'Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.', ' The word \\x1cnot\\x1d is missing from the following sentences \"do bandage tightly or cover with any type of wrap except clothing and \"do use with a heating pad or with other heat sources\\x1d in the Drug Facts panel \"Warning\" section', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014', 'Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.', 'Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.', 'Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.', 'Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. ', ' VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.', 'Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.', ' hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W002735, EXP: 6/6/2014', 'Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.', ' RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: W002619, EXP: 6/4/2014.', 'Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.', 'Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis. ', 'Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.', ' MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W002760, EXP: 6/6/2014', 'Labeling: Label Mixup: DICYCLOMINE HCL, Tablet, 20 mg may have potentially been mislabeled as the following drug: RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD76639_1, EXP: 5/31/2014. ', ' CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: W003750, EXP: 6/26/2014.', ' ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: W003028, EXP: 6/12/2014', 'CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.', ' The Lot and/or Expiration date on the tube may not be legible in this lot..', 'Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ACYCLOVIR, Tablet, 800 mg, NDC 00093894701, Pedigree: AD70629_1, EXP: 5/29/2014', 'Failed Dissolution Specification ', 'Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.', 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ', 'Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets. ', ' CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00', ' DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014', ' MULTIVITAMIN/MULTIMINERAL W/IRON, Chew Tablet, NDC 00536781601, Pedigree: W003018, EXP: 6/12/2014', 'Defective Container: Tamper evident ring failures discovered on some bottles. ', 'Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD49423_1, EXP: 5/16/2014', 'Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg) may have potentially been mislabeled as the following drug: PROPRANOLOL HCL, Tablet, 5 mg (1/2 of 10 mg), NDC 23155011001, Pedigree: AD73525_25, EXP: 5/30/2014.', 'Marketed without an approved NDA/ANDA', ' FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: AD65478_1, EXP: 5/29/2014.', 'Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.', ' HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.', ' TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001, Pedigree: AD25264_7, EXP: 5/3/2014.', ' LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: W003253, EXP: 6/17/2014. ', ' GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/40', 'Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe. ', 'Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. ', 'Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.', ' 12 month stability time point', ' OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP: 5/20/2014.', 'Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ', 'LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.', ' lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: A', 'Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 50 mg, NDC 65162064110, Pedigree: AD46414_16, EXP: 5/16/2014', 'Failed Stability Specifications: Low Out of Specification results for alcohol content.', ' product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug', ' CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, NDC 00904323392, Pedigree: AD54576_1, EXP: 5/20/2014', 'Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC 50111032701, Pedigree: AD49610_4, EXP: 5/16/2014', ' GUAIFENESIN, Tablet, 200 mg, NDC 00904515460, Pedigree: W002853, EXP: 6/7/2014', 'Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014', ' TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD73686_1, EXP: 5/31/2014. ', ' During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.', 'Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL', 'Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED). ', ' OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014', ' HYDROCHLOROTHIAZIDE Tablet, 12.5 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD46333_4, EXP: 5/16/2014.', ' CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD60240_42, EXP: 5/22/2014', ' fibers identified as cellulose and polyvinyl', 'Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as \"ointment\" instead of \"solution.\"', ' a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.', ' fluocinolone acetonide. ', ' ASCORBIC ACID Tablet, 500 mg may be potentially mislabeled as FEBUXOSTAT, Tablet, 40 mg, NDC 64764091830, Pedigree: AD23082_16, EXP: 11/1/2013.', 'Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.', 'Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed \"5 mL x 50,\" instead of \"10 mL x 50,\"', 'Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty re\\x10suspending particles.', 'Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.', ' POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, NDC 00486111101, Pedigree: AD52778_34, EXP: 5/20/2', 'Labeling: Label Mixup: DEXAMETHASONE, Tablet, 1 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL ER, Capsule, 150 mg, NDC 00093738656, Pedigree: AD30993_20, EXP: 5/9/2014. ', 'Labeling: Label Mixup: DESLORATADINE, Tablet, 5 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30180_28, EXP: 5/9/2014. ', ' Particulates identified as stainless steel and barium sulfate.', 'Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ', ' LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: AD65457_16, EXP: 5/24/2014', 'Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.', ' Lack of Assurance of Sterility', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD60272_70, EXP: 5/22/2014. ', ' GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: AD22865_4, EXP: 5/2/2014', 'Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.', 'Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD21790_70, EXP: 5/1/2014.', 'Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.', 'Labeling: Label Mix-up', 'Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).', 'Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014', 'Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.', ' CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014', ' possibility of Glipizide 10 mg tablets commingled', ' products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure', 'Presence of Foreign Substance(s)', 'Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.', 'Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.', 'Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.', 'Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014', ' MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014.', ' DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD70633_1, EXP: 5/29/2014', 'Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014. ', 'Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.', 'Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the \"y\" and \"3\" making the actual \"Use By 3/2015\" date appear to read \"Use By8/2015\".', 'Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.', 'Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014', \"Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. \", 'Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014', 'Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.', 'Subpotent', ' SEVELAMER CARBONATE, Tab', ' SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014. ', 'Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 25 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00378181701, Pedigree: W003151, EXP: 6/13/2014', ' The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. ', 'Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.', 'Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.', 'Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.', 'Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 120 mg, NDC 00093106001, Pedigree: AD49448_20, EXP: 5/17/2014', ' Ethinyl Estradiol', ' SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD37063_7, EXP: 5/13/2014.', 'Labeling: Label Mixup:MINOXIDIL, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD52778_43, EXP: 5/20/2014. ', 'Subpotent drug: low fill volume in some of the capsules', ' the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval', 'Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.', ' VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: W003083, EXP: 6/12/2014', ' hydrALAZINE HCl, Tablet, 50 mg, NDC 50111032801, Pedigree: AD52778_28, EXP: 5/20/2014', 'Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014', 'Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions', 'Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 74312002832, Pedigree: W003717, EXP: 6/26/2014', 'Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.', 'Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.', ' LEVOTHYROXINE/ LIOTHYRONINE, Tablet, 19 mcg/4.5 mcg, NDC 42192032901, Pedigree: AD30197_19, EXP: 3/31/2014', ' QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: W003099, EXP: 6/13/2014. ', 'Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014. ', 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. ', ' COENZYME Q-10, Capsule, 30 mg, NDC 00904501546, Pedigree: W002814, EXP: 6/7/2014. ', 'Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets. ', 'Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.', ' diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014', ' LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.', 'Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 00185004109, Pedigree: AD54549_7, EXP: 5/20/2014. ', 'Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles. ', ' ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD73652_19, EXP: 5/30/2014', 'Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.', 'Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.', 'Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors. ', 'Failed Stability Specifications: Unable to meet shelf life expiry.', ' MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014', 'Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.', 'Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.', \" Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.\", ' an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing ', 'Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.', ' DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD67992_4, EXP: 5/28/2014', 'Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.', 'Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.', 'Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.', 'Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.', 'Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).', ' various products were not stored at Controlled Room Temperature as per USP guidelines during shipping', 'Subpotent Drug: One lot Xanax (alprazolam) 0.25 mg tablets, was found to be below specification for assay (potency) at the 46 month time point.', 'Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.', ' RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.', ' hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg, NDC 00143117101, Pedigree: AD52778_16, EXP: 5/20/2014.', ' NABUMETONE, Tablet, 500 mg, NDC 00185014501, Pedigree: AD46426_4, EXP: 5/15/2014', ' acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: AD62865_1, EXP: 5/23/2014', 'Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.', 'Subpotent drug', ' THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedig', 'Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: TORSEMIDE, Tablet, 10 mg, NDC 50111091601, Pedigree: AD30197_25, EXP: 5/9/2014. ', ' defective valve', 'Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD46414_35, EXP: 5/16/2014.', 'Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.', 'Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.', 'Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. ', 'Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).', 'Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.', ' QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014. ', \"cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.\", 'Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles', 'Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD46265_22, EXP: 5/15/2014', ' GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, NDC 00904559293, Pedigree: AD60211_17, EXP: 5/22/2014. ', 'Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.', ' FOSINOPRIL SODIUM Tablet, 10 mg may be potentially mislabeled as CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD46414_10, EXP: 5/16/2014.', ' CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014', 'Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.', 'Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014', ' heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing', 'Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials', ' FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance', ' FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD62829_8, EXP: 5/23/2014', 'Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.', ' Glass particulates observed in vials', 'Labeling: Label Error On Declared Strength: The side label description incorrectly states \"Each mL contains 500 mcg Clonidine Hydrochloride\" instead of stating \"Each mL contains 100 mcg Clonidine Hydrochloride\".', 'Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.', 'Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP: 5/21/2014. ', ' confirmed results by FDA analysis after customer complaints of discoloration ', 'Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30\\x19s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse. ', ' CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014', 'Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%). ', ' CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD42592_1, EXP: 5/14/2014', ' VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014. ', 'Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.', ' traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014', ' NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013. ', 'Labeling: Presence of Undeclared Color Additive', 'Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.', 'Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.', 'Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, NDC 00603254421, Pedigree: W002654, EXP: 6/4/2014. ', \"Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. \", ' BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014. ', ' MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014. ', 'Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.', 'Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree: AD52778_88, EXP: 5/21/2014. ', 'Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_34, EXP: 5/22/2014', ' blister cavities may contain more than one tablet /capsule', 'Non-sterility: due to a failed sterility test ', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: W003358, EXP: 6/19/2014. ', 'Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. ', 'Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD30180_19, EXP: 5/9/2014', 'Labeling: Label Mixup', ' damaged blister units ', 'Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ', 'Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.', 'Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W003843, EXP: 6/27/2014', ' ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.', 'Labeling: Label Mixup: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: SEVELAMER HCL, Tablet\\t800 mg, NDC 58468002101, Pedigree: W002858, EXP: 6/7/2014.', 'Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.', ' may have a low frequency assembly fault which may result in pens block during the so-called \"air shot\" step', 'Defective container', 'Labeling: Labeling Bears Unapproved Claims', 'Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met. ', 'Labeling: Label Mixup: PROGESTERONE, Capsule, 100 mg may be potentially mislabeled as the following drug: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD46265_40, EXP: 5/15/2014. ', 'Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014', ' Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked \\x1cSyphon Tube\\x1d indicating liquid withdrawal and shipped as a gas withdrawal cylinder.', 'Labeling: Label Mix-up: Product was incorrectly labeled,\"Tabs\" instead of \"Capsules.\"\\x1d', 'Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014. ', 'Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 11845014882, Pedigree: AD70700_7, EXP: 5/29/2014', ' ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD28322_10, EXP: 5/6/2014.', 'Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing. ', 'Discoloration: presence of atypical yellow discoloration of the solution .', ' CHOLECALCIFEROL, Capsule, 2000 units, ND', 'Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 200 mg may have potentially been mislabeled as the following drug: NEFAZODONE HCL, Tablet, 150 mg, NDC 00093711306, Pedigree: AD46414_41, EXP: 5/16/2014.', ' CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD73623_1, EXP: 5/30/2014', 'Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.', ' BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD54478_1, EXP: 5/20/2014', 'Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.', 'Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point. ', ' SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZOLE, Capsule, 100 mg, NDC 10147170003, Pedigree: AD54549_10, EXP: 5/20/2014.', ' PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.', 'Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.', ' Firm states that erroneous potency information was found on the label.', 'Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. ', 'Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.', ' product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED) ', ' GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400', 'Crystallization: Formation of crystals observed in product.', 'CGMP Deviations: Cylinders filled using out of date gauges.', ' recall initiated by manufacturer due to reports of wet capsules ', ' incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018', ' potential leakage from administrative port.', 'Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory. ', ' PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree:', 'Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.', ' Sr-82 levels exceeded alert limit specification ', 'Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing. ', ' LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00074929690, Pedigree: AD22865_16, EXP: 5/2/2014', 'Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.', 'Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.', 'Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.', 'Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014', 'Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.', ' OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73', 'Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks', 'Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.', ' OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001, Pedigree: AD46265_37, EXP: 5/15/2014', ' MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68', ' PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD25452_7, EXP: 5/3/2014', 'Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.', 'Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014. ', ' PERPHENAZINE, Tablet, 16 mg, NDC', 'Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.', 'Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD46257_19, EXP: 5/15/2014', ' PYRIDOXINE HCL Tablet, 50 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: W002699, EXP: 6/5/2014', 'Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.', 'Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.', ' side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol ', 'Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets', 'Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.', ' OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014', 'Penicillin Cross Contamination: potentially contaminated with penicillin', 'Lack of Sterility Assurance: customer report of leaking bag', ' VERAPAMIL HCL, Tablet, 40 mg, NDC 00591040401, Pedigree: W003170, EXP: 6/13/2014. ', 'Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD54516_1, EXP: 5/20/2014', 'Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.', 'Marketed Without an Approved ANDA/NDA: presence of sildenafil. ', ' 500 mg capsules were found in bottles labeled to contain 250 mg capsules', ' ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014', ' ZINC SULFATE, Capsule, 50 mg, NDC 00904533260, Pedigree: AD30994_8, EXP: 5/9/2014. ', 'Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014', 'Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording \"Rx Only\".', 'Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: W003154, EXP: 6/13/2014. ', 'Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.', 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ', 'Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.', 'Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.', 'Defective Container: Pump head detaching from the canister unit upon removal of the overcap.', 'Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, \"Tamper Evident: Do not use if printed seal around cap is broken or missing.\" Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.', ' products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug', 'Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. ', ' LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD62796_1, EXP: 5/22/2014. ', ' 12 month acid dissolution test results were above upper limit specifications.', 'Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.', ' 15 month stability (by mfr)', ' RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.', ' PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014', ' REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD464', 'Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg) may have potentially been mislabeled as the following drug:, LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD46312_1, EXP: 5/16/2014. ', 'Failed pH specification', ' FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: W003097, EXP: 6/13/2014. ', 'Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD33897_13, EXP: 5/9/2014', 'Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), NDC 00904506260, AD46257_43, EXP: 5/15/2014', 'Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.', 'Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.', ' BENAZEPRIL HCL, Tablet, 5 mg, NDC 65162075110, Pedigree: AD52778_7, EXP: 5/20/2014', 'Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs. ', ' THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, EXP: 5/20/2014. ', ' PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: W003117, EXP: 6/13/2014.', 'Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.', ' ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/25', 'CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ', 'Marketed Without an Approved ANDA/NDA: presence of sibutramine', 'Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide ', 'Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.', 'Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.', 'Subpotent Drug: Heparin raw material was found to have low potency ', ' VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLUOPERAZINE HCL, Tablet, 1 mg, NDC 00781103001, Pedigree: AD52778_91, EXP: 5/21/2014.', ' LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002694, EXP: 6/5/2014', 'Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 04746900466, Pedigree: AD21846_17, EXP: 5/1/2014', 'Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ', 'Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may have potentially been mislabeled as the following drug: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, NDC 00591042401, Pedigree: W002900, EXP: 6/10/2014.', ' Product contains undeclared diclofenac and methocarbamol.', ' hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003008, EXP: 6/11/2014. ', 'Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.', ' NIACIN, Tablet, 100 mg, NDC 00904227160, Pedigree: W002661, EXP: 6/5/2014', 'Labeling: Label Mixup: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 00093746556, Pedigree: AD42592_7, EXP: 5/14/2014. ', 'Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014', 'Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.', 'Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 50 mg may have potentially been mislabeled as the following drug: MINOXIDIL, Tablet, 2.5 mg, NDC 00591564201, Pedigree: AD52778_49, EXP: 5/20/2014. ', 'Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.', ' The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t', 'Non Sterility', 'Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. ', 'Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: AD42566_1, EXP: 5/14/2014. ', 'Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.', 'Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product. ', ' PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W002697, EXP: 6/5/2014. ', ' PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD65457_1, EXP: 5/23/2014', \"Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory. \", 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ', ' DESMOPRESSIN ACETATE, Tablet, 0.1 mg, NDC 00591246401, Pedigree: AD46426_16, EXP: 5/15/2014', 'All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.', 'Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD49448_1, EXP: 5/17/2014', 'Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes', 'Impurities/Degradation Products: exceeded specification at 3 month stability testing ', ' SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014. ', 'Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX W/C, Tablet, 0, NDC 00536730001, Pedigree: AD52993_7, EXP: 5/20/2014', 'Lack of Assurance of Sterility ', ' RASAGILINE MESYLATE, Tablet, 0.5 mg, NDC 68546014256, Pedigree: W002929, EXP: 6/10/2014. ', ' GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014. ', 'Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets', ' ESZOPICLONE, T', ' Presence of co-mingled LipaCreon 13000.', 'Presence of Paticulate Matter', 'Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.', ' ESTERIFIED ESTROGENS, Tablet, 0.625 mg may be potentially mislabeled as ETODOLAC, Tablet, 400 mg, NDC 51672401801, Pedigree: W003734, EXP: 6/26/2014.', 'Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.', ' LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD60240_20, EXP: 5/22/2014', 'Labeling: Label Mixup: TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: AD30028_31, EXP: 5/8/2014.', 'Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial', 'Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing ', 'Crystallization', 'Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.', ' NITROFURANTOIN MACROCRYSTALS, Capsule, 50 mg, NDC 47781030701, Pedigree: AD25452_4, EXP: 5/3/2014', ' BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC 00093102506, Pedigree: AD46414_44, EXP: 5/16/2014', ' Product Contains Undeclared API (Oxybenzone)', 'Labeling: Label Mixup: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg may have potentially been mislabeled as the following drug: ASPIRIN, Tablet, 325 mg, NDC 49348000123, Pedigree: W002640, EXP: 6/4/2014. ', 'Lack of sterility assurance', 'Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.', ' Out of specification for lactol and total impurities.', 'Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.', 'Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.', 'Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.', 'Defective Container: Confirmed customer complaints of leaking bottles. ', 'Failed dissolution specifications', ' OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: AD42592_4, EXP: 5/14/2014.', 'Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.', ' the correct date is 09/17. ', 'Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.', 'Presence of Foreign Substance: Presence of hair.', ' VITAMIN B COMPLEX W/C Capsule may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD39560_1, EXP: 5/13/2014.', 'Failed Impurities/Degradation Specifications: 3 month stability testing. ', 'Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.', ' guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003514, EXP: 6/21/2014. ', 'Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.', 'Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.', 'Defective Container: Lids on unit dose cups are not fully qualified.', 'Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003327, EXP: 6/19/2014. ', ' out of specification for trans-calcitriol degradant at the 9 month stability time point', 'Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.', 'Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.', 'CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.', ' guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W003689, EXP: 6/26/20', ' PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: W003694, EXP: 6/26/2014.', ' CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003716, EXP: 6/26/2014', ' particulate found in retain samples', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: W003007, EXP: 6/12/2014. ', 'Failed Impurities/Degradation Specifications ', ' CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003113, EXP: 6/13/2014', 'Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. ', ' DISULFIRAM Tablet, 250 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_22, EXP: 5/2/2014.', ' AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003674, EXP: 6/25/2014', ' CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD37088_4, EXP: 5/9/2014.', ' PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD68010_11, EXP: 5/28/2014.', ' CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.', 'Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point', 'Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.', ' Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.', ' FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD32328_5, EXP: 5/9/2014', 'Defective Container: Leakage of unit dose cups that may occur at the seal.', 'Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.', 'Lack of Assurance of Sterility: There are also CGMP Deviations. ', ' complaints received by the manufacturer of crystals forming in product', 'Failed Moisture Limit', 'Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. ', 'Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled', ' RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201, Pedigree: AD54549_13, EXP: 5/20/2014', 'Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. ', 'Presence of Particulate Matter.', 'Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00536406001, Pedigree: AD22865_13, EXP: 5/2/2014. ', ' FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014', 'Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the following drug: NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD46414_47, EXP: 5/16/2014. ', 'Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD73597_1, EXP: 5/31/2014. ', 'Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W003749, EXP: 6/26/2014. ', 'Crystallization: Product contains particulate identified to be crystallized active ingredient.', ' CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014', ' PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213, Pedigree: AD23082_13, EXP: 11/1/2013', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD21846_1, EXP: 5/1/2014.', 'Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates. ', \"Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.\", 'Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.', ' MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014', 'Labeling: Label Mixup: DILTIAZEM HCL, Tablet, 120 mg, may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: AD329737, EXP: 5/9/2014. ', 'Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point. ', 'Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life. ', 'Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates', ' Incorrect or Missing Lot and/or Exp Date', ' LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W002730, EXP: 6/6/2014', ' product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug', 'Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.', 'Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.', 'Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product', ' defective seals where the metal silver ring was not attached tightly to the vial', 'Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701', 'Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.', 'Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.', 'Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.', ' The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.', 'Defective container: Product distributed without inner seal on bottles.', 'Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.', 'Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg, NDC 16714058501, Pedigree: W003761, EXP: 6/26/2014. ', 'Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.', 'Presence of Foreign Substance: Presence of stainless steel particles.', 'Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.', ' NEOMYCIN SULFATE, Tablet, 500 mg may be potentially mislabeled as IMIPRAMINE HCL, Tablet, 25 mg, NDC 00781176401, Pedigree: AD49448_10, EXP: 5/17/2014.', \"Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products. \", 'Superpotent and Subpotent drugs ', 'Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.', 'Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.', 'Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.', 'Labeling: Label Mixup: REPAGLINIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD52372_1, EXP: 5/17/2014', 'Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).', ' FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.', 'Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD32325_4, EXP: 5/9/2014', 'Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.', 'Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD46265_49, EXP: 5/15/2014', 'CGMP Deviations', 'Unit Dose Mispackaging', 'Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.', ' the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.', ' CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014', 'Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014. ', 'Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.', 'Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.', 'Labeling: Label Mixup: ASCORBIC ACID, CHEW Tablet, 500 mg may have potentially been mislabeled as the following drug: PHENOL, LOZENGE, 29 mg, NDC 00068021918, Pedigree: AD60428_4, EXP: 5/22/2014. ', ' CHOLECALCIFEROL, Tablet, ', ' PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 100 mcg, NDC 00536354201, Pedigree: AD62840_1, EXP: 5/24/2014.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014. ', 'CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.', ' HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, NDC 00574024701, Pedigree: W003614, EXP: 6/25/2014. ', ' 9 month stability timepoint', 'Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. ', 'Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.', 'Non-Sterility: Product tested positive for bacterial contamination.', 'Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.', 'Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date. ', 'Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity', 'Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4 mg, NDC 60258085001, Pedigree: W003676, EXP: 6/25/2014', 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ', ' CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003615, EXP: 6/25/2014. ', ' white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.', 'Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.', 'Superpotent Drug: Product contains twice the stated amount of midazolam.', ' LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014. ', ' CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD46257_59, EXP: 5/15/2014', 'Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.', 'Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.', 'Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.', 'Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. ', 'Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules. ', 'Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life', ' PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD28322_4, EXP: 4/30/2014', 'Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.', 'Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.', 'Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..', 'Failed USP Content Uniformity Requirements: OOS result reported on retained samples.', 'Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62865_4, EXP: 5/23/2014.', 'Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014', 'Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.', ' 15 month stability', ' some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP', 'Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp. ', ' MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: W002513, EXP: 6/3/2014. ', 'Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.', ' METOPROLOL SUCCINATE ER, Tablet, 200 mg may be potentially mislabeled as Pedigree: AD73652_13, EXP: 5/30/2014. ', ' IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014', 'cGMP deviations', ' out of specification for the known impurity 4-chlorobenzophenone. ', 'Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014', ' VENLAFAXINE HCL, Tablet, 75 mg, NDC 00093738201, Pedigree: W002533, EXP: 2/28/2014', ' ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD46426_10, EXP: 5/15/2014.', 'Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.', 'Labeling: Incorrect or Missing Lot AND/OR Exp Date. ', 'Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.', ' HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: AD54501_1, EXP: 5/21/2014', ' CETIRIZINE HCL, Tablet, 5 mg, NDC 00378363501, Pedigree: AD32757_13, EXP: 5/13/2014', 'Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.', 'Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.', ' LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.', 'Penicillin Cross Contamination.', 'Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.', ' CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014. ', 'Subpotent Drug: Phenylephrine component is subpotent.', 'Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.', ' OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: AD21790_73, EXP: 5/1/2014.', 'Labeling: Not elsewhere classified - count on the label was incorrect.', 'Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.', 'Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. ', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD46265_1, EXP: 5/15/2014', 'Presence of Foreign Substance: foreign material found in the bulk inventory.', ' SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W002857, EXP: 6/7/2014.', 'Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014', 'Superpotent Drug: Out Of Specification (OOS) result for Assay. ', 'Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product\\'s name includes the word \"Children\\'s\" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.', 'Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as one of the following drugs: ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), NDC 00904533260, Pedigree: AD57624_1, EXP: 5/9/2014', 'Lack of Assurance of Sterility: Failed preservative effectiveness testing', 'Labeling: Missing label', ' MULTIVITAMIN/M', 'Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial. ', 'Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.', 'Microbial contamination of Non Sterile Product', 'Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. ', 'Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.', ' LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_31, EXP: 5/13/2014', 'Failed Tablet/Capsule Specifications: Presence of split or broken tablets.', 'Superpotent (Single Ingredient Drug): salicylic acid ', 'Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.', 'Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: AD73637_1, EXP: 5/30/2014. ', 'Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.', ' LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: AD22865_7, EXP: 5/2/2014', 'Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.', 'Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.', ' oxidized steel, organic material and shredded polypropylene', 'Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring. ', 'Correct Labeled Product Mispacked', 'Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ', ' PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD73525_52, EXP: 5/30/2014.', ' SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014. ', 'Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, EXP: 6/20/2014. ', 'Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.', 'Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.', ' product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate). ', 'Defective Container: Vials may be missing stoppers.', 'Miscalibrated/Defective Delivery System', 'Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.', ' METHOCARBAMOL, Tablet, 500 mg, NDC 00143129001, Pedigree: AD46312_28, EXP: 5/16/2014', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17', 'CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.', 'Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.', 'Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance. ', 'Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.', ' 12 month stability testing (Expansion of RES #70548).', ' NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: AD52433_1, EXP: 5/17/2014', ' MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003022, EXP: 6/12/2014', 'Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. ', 'Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.', 'Labeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W003218, EXP: 6/17/2014.', 'Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.', 'Defective Delivery System: Some units have actuation counters set to a number other than 60.', 'Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.', 'Labeling: Label Mixup: ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 0 mg, NDC 42865010302, Pedigree: W003354, EXP: 6/19/2014', 'cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. ', 'Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components. ', 'Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.', 'Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.', ' PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: W003682, EXP: 6/25/2014. ', 'Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s). ', 'Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station', 'Failed dissolution specifications - low dissolution results at S3 stage.', ' ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 60505257909, Pedigree: W003846, EXP: 6/27/2014', 'Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution ', 'Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.', 'Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.', 'Labeling: Missing Label', 'Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.', ' CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, NDC 00005550924, Pedigree: AD52993_1, EXP: 5/17/2014', ' \"Related Compound C\" ', 'Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).', 'Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.', 'Failed impurities/degradation: out of specification result for impurity secorapamycin.', 'Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance. ', ' damage to the internal portion of the dropper tip portion of the container', 'Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.', 'Failed Dissolution Specification', 'Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).', 'Microbial Contamination of Non Sterile Products', 'Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.', 'Failed Impurities/Degradation Specifications: out of specification for unknown impurity', ' amLOD', 'Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.', 'Failed pH Specifications: product was too acidic.', 'Labeling: Label Mixup: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD21787_1, EXP: 5/1/2014', 'Failed Tablet/Capsule Specifications: There is a potential for broken tablets.', 'Lack of Assurance of Sterility: Failed preservative effectiveness testing.', 'Labeling: Label Mixup: ISONIAZID, Tablet, 300 mg may have potentially been mislabeled as one of the following drugs: hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003690, EXP: 6/26/2014', ' MELATONIN, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003711, EXP: 6/26/2014.', 'Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.', ' sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014.', 'Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.', 'Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.', ' FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014. ', 'Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.', ' acetaZOLAMIDE', ' METAXALONE, Tablet, 800 mg, NDC 64720032110, Pedigree: W003738, EXP: 6/26/2014', 'Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.', ' TACROLIMUS, Capsule, 0.5 mg, NDC 00781210201, Pedigree: W003169, EXP: 6/13/2014', ' ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003526, EXP: 6/21/2014', 'Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.', ' guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.', ' PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121207, Pedigree: AD70639_7, EXP: 5/29/2014', ' NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014', ' at the 12 month time interval.', ' VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_1, EXP: 5/8/2014', ' ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014. ', ' ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD39588_1, EXP: 5/13/2014. ', 'Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.', 'Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.', 'Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD21846_34, EXP: 5/1/2014', ' CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003024, EXP: 6/12/2014', ' QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598, Pedigree: AD22845_4, EXP: 5/2/2014.', ' CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014.', 'Labeling: Label Mixup:TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) may have potentially been mislabeled as the following drug: PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD73525_22, EXP: 5/30/2014. ', 'Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids', 'Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.', 'Labeling: Label Mixup: THYROID, Tablet, 60 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: W002847, EXP: 6/7/2014.', ' ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: W003714, EXP: 6/26/2014.', 'Subpotent Drug and Failed Impurities/Degradation Specifications', 'Labeling', 'Active Ingredients per dose&quot', 'Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.', ' FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003764, EXP: 6/26/2014. ', ' TORSEMIDE, Tablet, 10 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD30197_22, EXP: 5/9/2014.', ' rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC 00143117201, Pedigree: AD52778_19, EXP: 5/20/2014.', ' traZODone HCl, Tablet, 50 mg, NDC 50111043303, P', 'Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell. ', ' and may have potentially been mislabeled as one of the following drugs: methylPREDNISolone, Tablet, 4 mg, NDC 00603459321, Pedigree: AD32764_11, EXP: 3/31/2014', 'Marketed Without an Approved NDA/ANDA', 'Subpotent Drug', 'Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months. ', 'Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD52778_82, EXP: 5/21/2014.', 'Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.', ' exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value', 'Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.', 'Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.', ' GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg may be potentially mislabeled as FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD60240_30, EXP: 5/22/2014.', 'Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.', ' MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD52993_31, EXP: 5/17/2014', 'Lack of Assurance of Sterility: incomplete or missing data regarding production.', ' MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014', ' HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014. ', ' PREGABALIN, Capsule, 25 mg, NDC 00071101268, Pedigree: W003121, EXP: 6/13/2014', 'Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400 mg, NDC 67877029401, Pedigree: W002577, EXP: 6/3/2014', ' NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.', 'Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved', 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. ', ' CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD73521_7, EXP: 5/30/2014. ', 'Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b', 'Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.', 'Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 75 mg may have potentially been mislabeled as the following drug: TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W002508, EXP: 6/3/2014. ', 'Superpotent', 'CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.', ' TACROLIMUS, Capsule, 1 mg, NDC 00781210', ' METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68022_1, EXP: 5/28/2014', 'Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine', ' LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU, NDC 43292050022, Pedigree: AD30028_10, EXP: 5/7/2014. ', 'Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg may have potentially been mislabeled as one of the following drugs: sitaGLIPtin PHOSPHATE, Tablet, 50 mg, NDC 00006011231, Pedigree: AD62829_11, EXP: 5/23/2014', 'Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.', ' DESIPRAMINE HCL Tablet, 50 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD30140_4, EXP: 5/7/2014.', 'Failed Dissolution Specifications: Low out of specification dissolution results.', ' METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 57664050652, Pedigree: AD68010_14, EXP: 5/28/2014. ', 'Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. ', ' SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014', 'Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 \"Capsules\" (3 x 10) rather than \"Tablets\". ', 'Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.', ' ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: W003094, EXP: 6/13/2014. ', ' NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014', ' analytical results found product to contain Sphingomonas paucimobilis', 'Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC 51991073801, Pedigree: AD49448_17, EXP: 5/17/2014.', 'Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.', 'cGMP deviation', ' PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP: 6/7/2014.', ' rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. ', 'Failed Impurities/Degradation Specifications: out of specification impurity test results. ', 'Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ', \" the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.\", ' MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: AD33897_25, EXP: 5/9/2014', 'Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured. ', ' LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014. ', 'Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. ', 'Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.', ' Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.', ' potential to have inaccurate dosage delivery', 'Failed Dissolution Specifications: 6 month time point.', ' ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014. ', ' RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014', 'Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine', 'Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014. ', 'Failed tablet specifications: One lot was found to contain oversized tablets.', ' BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00781532531, Pedigree: AD32579_7, EXP: 5/9/2014', ' MONTELUKAST SODIUM, CHEW Tablet, 4 mg, NDC 00006071131, Pedigree: AD76639_11, EXP: 5/31/2014. ', ' MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141503, Pedigree: AD73525_55, EXP: 5/30/2014. ', 'Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.', 'Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.', ' IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer', 'Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.', ' AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003323, EXP: 6/18/2014. ', 'CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.', 'Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg ', 'Labeling: Label Mixup:NICOTINE POLACRILEX, GUM, 2 mg may have potentially been mislabeled as one of the following drugs: FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: AD33897_22, EXP: 5/9/2014', 'Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52412_11, EXP: 5/17/2014. ', 'Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.', 'Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.', 'Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet, 0.5 mg, NDC 00555089902, Pedigree: AD30993_11, EXP: 5/9/2014', ' VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003789, EXP: 6/27/2014', 'Failed Stability Testing: This product is below specification for preservative content.', ' Labeling: Label Mix-up: Pitocin storage conditions should be labeled, \"Store between 20¿ to 25¿C (68¿ to 77¿F)\". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, \"Store between 20¿ to 25¿C (28¿ to 77¿F)\". ', 'The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.', 'Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.', 'Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.', 'Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole. ', 'Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. ', ' OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002509, EXP: 6/3/2014', 'Microbial Contamination of Non-Sterile Products', ' LACTASE ENZYME, Tab', 'Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. ', 'Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.', ' COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree', 'Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD30140_16, EXP: 5/7/2014', 'Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.', ' LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD42584_1, EXP: 5/14/2014. ', 'Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.', 'Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.', ' some bottles may contain debris that was swept up during cleaning', 'Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.', 'Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.', ' CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 00378022201, Pedigree:', 'Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD30180_1, EXP: 5/8/2014', 'Failed Impurity/Degradation Specification', ' COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as rifAXIMin, Tablet, 200 mg, NDC 65649030103, Pedigree: AD54587_10, EXP: 4/30/2014.', 'Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.', 'Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.', 'Labeling: Label Mixup: VALSARTAN, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD52372_4, EXP: 5/17/2014', ' VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014. ', 'Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003726, EXP: 6/26/2014', 'Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.', 'CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. ', 'Labeling:Label Mixup', 'Labeling: Label Mixup: DOXYCYCLINE HYCLATE, Capsule, 100 mg may have potentially been mislabeled as the following drug: RALOXIFENE HCL, Tablet, 60 mg, NDC 00002416530, Pedigree: W002644, EXP: 6/5/2014.', 'Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point', ' FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP: 6/28/2014.', ' DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014', 'Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a \"foreign material\", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg. ', 'Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.'}\n"
]
}
],
"source": [
"all_uniq_reasons = get_reason_for_recall()\n",
"print('number of unique reasons :', len(all_uniq_reasons))\n",
"print('Reasons :', all_uniq_reasons)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Classes for each drug recalls"
]
},
{
"cell_type": "code",
"execution_count": 6,
"metadata": {
"collapsed": true
},
"outputs": [],
"source": [
"# a dictionary mapping each source id (from the list displayed above) to the corresponding news category\n",
"def mapping():\n",
" d = {}\n",
" response = requests.get('https://newsapi.org/v1/sources?language=en')\n",
" response = response.json()\n",
" for s in response['sources']:\n",
" d[s['id']] = s['category']\n",
" return d"
]
},
{
"cell_type": "code",
"execution_count": 10,
"metadata": {
"collapsed": false
},
"outputs": [
{
"name": "stdout",
"output_type": "stream",
"text": [
"categories: ['science-and-nature', 'entertainment', 'technology', 'gaming', 'business', 'music', 'sport', 'general']\n"
]
}
],
"source": [
"# let's see what categories we have:\n",
"print('categories:', list(set(m.values())))"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Ok, now this script needs to run repetitively to collect the data. "
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Now that the data has been collected, we will start anlayzing it :\n",
"\n",
"- We'll have a look at the dataset and inspect it\n",
"- We'll apply some preoprocessings on the texts: tokenization, tf-idf\n",
"- We'll cluster the articles using two different algorithms (Kmeans and LDA)\n",
"- We'll visualize the clusters using Bokeh and pyldavis"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"## Step 3: Data analysis"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"[[ go back to the top ]](#Table-of-contents)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"### Data discovery\n",
"[[ go back to the top ]](#Table-of-contents)"
]
},
{
"cell_type": "code",
"execution_count": 27,
"metadata": {
"collapsed": false
},
"outputs": [],
"source": [
"%matplotlib inline\n",
"# pandas for data manipulation\n",
"import pandas as pd\n",
"pd.options.mode.chained_assignment = None\n",
"# nltk for nlp\n",
"from nltk.tokenize import word_tokenize, sent_tokenize\n",
"from nltk.corpus import stopwords\n",
"# list of stopwords like articles, preposition\n",
"stop = set(stopwords.words('english'))\n",
"from string import punctuation\n",
"from collections import Counter\n",
"import re\n",
"import numpy as np"
]
},
{
"cell_type": "code",
"execution_count": 28,
"metadata": {
"collapsed": true
},
"outputs": [],
"source": [
"with open('drug-enforcement-0001-of-0001.json') as data_file: \n",
" drug_data = json.load(data_file)"
]
},
{
"cell_type": "code",
"execution_count": 29,
"metadata": {
"collapsed": false
},
"outputs": [],
"source": [
"data = pd.DataFrame.from_records(drug_data['results'])"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"The data is now ingested in a Pandas DataFrame.\n",
"\n",
"Let's see how it looks like."
]
},
{
"cell_type": "code",
"execution_count": 30,
"metadata": {
"collapsed": false
},
"outputs": [
{
"data": {
"text/html": [
"<div>\n",
"<table border=\"1\" class=\"dataframe\">\n",
" <thead>\n",
" <tr style=\"text-align: right;\">\n",
" <th></th>\n",
" <th>address_1</th>\n",
" <th>address_2</th>\n",
" <th>center_classification_date</th>\n",
" <th>city</th>\n",
" <th>classification</th>\n",
" <th>code_info</th>\n",
" <th>country</th>\n",
" <th>distribution_pattern</th>\n",
" <th>event_id</th>\n",
" <th>initial_firm_notification</th>\n",
" <th>...</th>\n",
" <th>product_type</th>\n",
" <th>reason_for_recall</th>\n",
" <th>recall_initiation_date</th>\n",
" <th>recall_number</th>\n",
" <th>recalling_firm</th>\n",
" <th>report_date</th>\n",
" <th>state</th>\n",
" <th>status</th>\n",
" <th>termination_date</th>\n",
" <th>voluntary_mandated</th>\n",
" </tr>\n",
" </thead>\n",
" <tbody>\n",
" <tr>\n",
" <th>0</th>\n",
" <td>7050 Camp Hill Rd</td>\n",
" <td></td>\n",
" <td>20120702</td>\n",
" <td>Fort Washington</td>\n",
" <td>Class III</td>\n",
" <td>Lot #CMF023, Expiration 07/13.</td>\n",
" <td>United States</td>\n",
" <td>Nationwide</td>\n",
" <td>61872</td>\n",
" <td>Letter</td>\n",
" <td>...</td>\n",
" <td>Drugs</td>\n",
" <td>Defective Container; damaged blister units</td>\n",
" <td>20120517</td>\n",
" <td>D-1404-2012</td>\n",
" <td>Mcneil Consumer Healthcare, Div Of Mcneil-ppc,...</td>\n",
" <td>20120711</td>\n",
" <td>PA</td>\n",
" <td>Terminated</td>\n",
" <td>20130411</td>\n",
" <td>Voluntary: Firm Initiated</td>\n",
" </tr>\n",
" <tr>\n",
" <th>1</th>\n",
" <td>600 N Field Dr Bldg J45</td>\n",
" <td></td>\n",
" <td>20120620</td>\n",
" <td>Lake Forest</td>\n",
" <td>Class III</td>\n",
" <td>Lot #: 04510KL*, Exp 01OCT2012; *lot number m...</td>\n",
" <td>United States</td>\n",
" <td>Nationwide</td>\n",
" <td>62053</td>\n",
" <td>Letter</td>\n",
" <td>...</td>\n",
" <td>Drugs</td>\n",
" <td>Superpotent (Single Ingredient) Drug: Above sp...</td>\n",
" <td>20120405</td>\n",
" <td>D-1390-2012</td>\n",
" <td>Hospira, Inc.</td>\n",
" <td>20120627</td>\n",
" <td>IL</td>\n",
" <td>Terminated</td>\n",
" <td>20130808</td>\n",
" <td>Voluntary: Firm Initiated</td>\n",
" </tr>\n",
" <tr>\n",
" <th>2</th>\n",
" <td>12515 E 55th St Ste 100</td>\n",
" <td></td>\n",
" <td>20120618</td>\n",
" <td>Tulsa</td>\n",
" <td>Class I</td>\n",
" <td>PTC Drug Number: 4033. PTC Batch Number: 65I...</td>\n",
" <td>United States</td>\n",
" <td>FL</td>\n",
" <td>61233</td>\n",
" <td>FAX</td>\n",
" <td>...</td>\n",
" <td>Drugs</td>\n",
" <td>Labeling: Label mix-up; Bottles labeled to con...</td>\n",
" <td>20101110</td>\n",
" <td>D-1385-2012</td>\n",
" <td>Physicians Total Care, Inc</td>\n",
" <td>20120627</td>\n",
" <td>OK</td>\n",
" <td>Terminated</td>\n",
" <td>20120724</td>\n",
" <td>Voluntary: Firm Initiated</td>\n",
" </tr>\n",
" <tr>\n",
" <th>3</th>\n",
" <td>150 Signet Drive</td>\n",
" <td></td>\n",
" <td>20120802</td>\n",
" <td>Toronto</td>\n",
" <td>Class II</td>\n",
" <td>Lot #s: JN1060, JN1061, JN1062, Exp 06/12</td>\n",
" <td>Canada</td>\n",
" <td>Nationwide and Puerto Rico</td>\n",
" <td>62574</td>\n",
" <td>Letter</td>\n",
" <td>...</td>\n",
" <td>Drugs</td>\n",
" <td>Presence of Particulate Matter: Lots identifi...</td>\n",
" <td>20120430</td>\n",
" <td>D-1439-2012</td>\n",
" <td>Apotex Inc.</td>\n",
" <td>20120808</td>\n",
" <td></td>\n",
" <td>Terminated</td>\n",
" <td>20130919</td>\n",
" <td>Voluntary: Firm Initiated</td>\n",
" </tr>\n",
" <tr>\n",
" <th>4</th>\n",
" <td>200 Somerset Corporate Blvd Fl 7th</td>\n",
" <td></td>\n",
" <td>20120731</td>\n",
" <td>Bridgewater</td>\n",
" <td>Class II</td>\n",
" <td>C201293 Exp Date 08/2013</td>\n",
" <td>United States</td>\n",
" <td>Nationwide and Puerto Rico</td>\n",
" <td>62591</td>\n",
" <td>Letter</td>\n",
" <td>...</td>\n",
" <td>Drugs</td>\n",
" <td>Adulterated Presence of Foreign Tablets: Dr. R...</td>\n",
" <td>20120409</td>\n",
" <td>D-1434-2012</td>\n",
" <td>Dr. Reddy's Laboratories, Inc.</td>\n",
" <td>20120808</td>\n",
" <td>NJ</td>\n",
" <td>Terminated</td>\n",
" <td>20130124</td>\n",
" <td>Voluntary: Firm Initiated</td>\n",
" </tr>\n",
" </tbody>\n",
"</table>\n",
"<p>5 rows × 25 columns</p>\n",
"</div>"
],
"text/plain": [
" address_1 address_2 center_classification_date \\\n",
"0 7050 Camp Hill Rd 20120702 \n",
"1 600 N Field Dr Bldg J45 20120620 \n",
"2 12515 E 55th St Ste 100 20120618 \n",
"3 150 Signet Drive 20120802 \n",
"4 200 Somerset Corporate Blvd Fl 7th 20120731 \n",
"\n",
" city classification \\\n",
"0 Fort Washington Class III \n",
"1 Lake Forest Class III \n",
"2 Tulsa Class I \n",
"3 Toronto Class II \n",
"4 Bridgewater Class II \n",
"\n",
" code_info country \\\n",
"0 Lot #CMF023, Expiration 07/13. United States \n",
"1 Lot #: 04510KL*, Exp 01OCT2012; *lot number m... United States \n",
"2 PTC Drug Number: 4033. PTC Batch Number: 65I... United States \n",
"3 Lot #s: JN1060, JN1061, JN1062, Exp 06/12 Canada \n",
"4 C201293 Exp Date 08/2013 United States \n",
"\n",
" distribution_pattern event_id initial_firm_notification \\\n",
"0 Nationwide 61872 Letter \n",
"1 Nationwide 62053 Letter \n",
"2 FL 61233 FAX \n",
"3 Nationwide and Puerto Rico 62574 Letter \n",
"4 Nationwide and Puerto Rico 62591 Letter \n",
"\n",
" ... product_type \\\n",
"0 ... Drugs \n",
"1 ... Drugs \n",
"2 ... Drugs \n",
"3 ... Drugs \n",
"4 ... Drugs \n",
"\n",
" reason_for_recall recall_initiation_date \\\n",
"0 Defective Container; damaged blister units 20120517 \n",
"1 Superpotent (Single Ingredient) Drug: Above sp... 20120405 \n",
"2 Labeling: Label mix-up; Bottles labeled to con... 20101110 \n",
"3 Presence of Particulate Matter: Lots identifi... 20120430 \n",
"4 Adulterated Presence of Foreign Tablets: Dr. R... 20120409 \n",
"\n",
" recall_number recalling_firm \\\n",
"0 D-1404-2012 Mcneil Consumer Healthcare, Div Of Mcneil-ppc,... \n",
"1 D-1390-2012 Hospira, Inc. \n",
"2 D-1385-2012 Physicians Total Care, Inc \n",
"3 D-1439-2012 Apotex Inc. \n",
"4 D-1434-2012 Dr. Reddy's Laboratories, Inc. \n",
"\n",
" report_date state status termination_date voluntary_mandated \n",
"0 20120711 PA Terminated 20130411 Voluntary: Firm Initiated \n",
"1 20120627 IL Terminated 20130808 Voluntary: Firm Initiated \n",
"2 20120627 OK Terminated 20120724 Voluntary: Firm Initiated \n",
"3 20120808 Terminated 20130919 Voluntary: Firm Initiated \n",
"4 20120808 NJ Terminated 20130124 Voluntary: Firm Initiated \n",
"\n",
"[5 rows x 25 columns]"
]
},
"execution_count": 30,
"metadata": {},
"output_type": "execute_result"
}
],
"source": [
"data.head()"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"It's cool to have all these features. In this article, we will be mainly focusing on the description column.\n",
"\n",
"Let's look at the data shape."
]
},
{
"cell_type": "code",
"execution_count": 31,
"metadata": {
"collapsed": false
},
"outputs": [
{
"name": "stdout",
"output_type": "stream",
"text": [
"data shape: (7002, 25)\n"
]
}
],
"source": [
"print('data shape:', data.shape)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Let's check the distribution of the different categories across the dataset."
]
},
{
"cell_type": "code",
"execution_count": 33,
"metadata": {
"collapsed": false,
"scrolled": false
},
"outputs": [
{
"data": {
"text/plain": [
"<matplotlib.axes._subplots.AxesSubplot at 0x17b86aac630>"
]
},
"execution_count": 33,
"metadata": {},
"output_type": "execute_result"
},
{
"data": {
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qnpfk0LLZoSTnJ7m/qvYkeWaSv9gwfszG52z8GtcluS5J9u7d2/v27TupN7RbXXngllVP\n4bRwzUVH8ta7TuqP/a51z2v2rXoKsCutr6/H333AVPZRrMpWrir8nOVIa6rqzCQ/lOQzST6c5EeW\nza5I8v7l9s3L/SyPf6i7exl/9XLV4ecmuTDJH52qNwIAAMDOtJVDT+ckuXG5AvBTktzU3b9XVZ9O\n8p6q+sUkn0hy/bL99Ul+s6oOJnk4R68knO7+VFXdlOTTSY4kuXpZggwAAACbOmG4dvedSb7nOOOf\ny3GuCtzdf53kRzd5rTcnefPJTxMAAIDdaktXFQYAAIBVEa4AAACMJlwBAAAYTbgCAAAwmnAFAABg\nNOEKAADAaMIVAACA0YQrAAAAowlXAAAARhOuAAAAjCZcAQAAGE24AgAAMJpwBQAAYDThCgAAwGjC\nFQAAgNGEKwAAAKMJVwAAAEYTrgAAAIwmXAEAABhNuAIAADCacAUAAGA04QoAAMBowhUAAIDRhCsA\nAACjCVcAAABGE64AAACMJlwBAAAYTbgCAAAwmnAFAABgNOEKAADAaMIVAACA0YQrAAAAowlXAAAA\nRhOuAAAAjCZcAQAAGE24AgAAMJpwBQAAYDThCgAAwGjCFQAAgNGEKwAAAKMJVwAAAEYTrgAAAIwm\nXAEAABhNuAIAADCacAUAAGA04QoAAMBowhUAAIDRhCsAAACjCVcAAABGE64AAACMJlwBAAAYTbgC\nAAAwmnAFAABgNOEKAADAaMIVAACA0YQrAAAAowlXAAAARhOuAAAAjCZcAQAAGE24AgAAMJpwBQAA\nYDThCgAAwGjCFQAAgNGEKwAAAKMJVwAAAEYTrgAAAIwmXAEAABhNuAIAADCacAUAAGA04QoAAMBo\nwhUAAIDRThiuVXV+VX24qj5dVZ+qqtcv48+qqlur6u7l89nLeFXVO6rqYFXdWVUXb3itK5bt766q\nK568twUAAMBOsZUjrkeSXNPdz0tySZKrq+p5SQ4kua27L0xy23I/SV6W5MLlY3+SdyZHQzfJtUle\nlOSFSa49FrsAAACwmROGa3c/0N0fX25/Mclnkpyb5PIkNy6b3Zjklcvty5O8u4/6SJKzquqcJC9N\ncmt3P9zdjyS5Ncllp/TdAAAAsOOc1DmuVXVBku9J8tEka939wPLQg0nWltvnJrlvw9PuX8Y2GwcA\nAIBN7dnqhlX1t5L89yT/srv/sqq+9lh3d1X1qZhQVe3P0SXGWVtby/r6+ql42R3vmouOrHoKp4W1\nM32vtsrPHqzG4cOH/fwBY9lHsSpbCteqemqORutvdffvLsOfr6pzuvuBZSnwQ8v4oSTnb3j6ecvY\noST7Hje+/viv1d3XJbkuSfbu3dv79u17/CYcx5UHbln1FE4L11x0JG+9a8v/X7Or3fOafaueAuxK\n6+vr8XcfMJV9FKuylasKV5Lrk3ymu395w0M3Jzl2ZeArkrx/w/hrl6sLX5Lk0WVJ8QeTXFpVZy8X\nZbp0GQMAAIBNbeXQ0/cn+ckkd1XVJ5exn0/yliQ3VdVVSe5N8qrlsQ8keXmSg0keS/K6JOnuh6vq\nTUluX7Z7Y3c/fEreBQAAADvWCcO1u/9nktrk4ZccZ/tOcvUmr3VDkhtOZoIAAADsbid1VWEAAADY\nbsIVAACA0YQrAAAAowlXAAAARhOuAAAAjCZcAQAAGE24AgAAMJpwBQAAYDThCgAAwGjCFQAAgNGE\nKwAAAKMJVwAAAEYTrgAAAIwmXAEAABhNuAIAADCacAUAAGA04QoAAMBowhUAAIDRhCsAAACjCVcA\nAABGE64AAACMJlwBAAAYTbgCAAAwmnAFAABgNOEKAADAaMIVAACA0YQrAAAAowlXAAAARhOuAAAA\njCZcAQAAGE24AgAAMJpwBQAAYDThCgAAwGjCFQAAgNGEKwAAAKMJVwAAAEYTrgAAAIwmXAEAABhN\nuAIAADCacAUAAGA04QoAAMBowhUAAIDRhCsAAACjCVcAAABGE64AAACMJlwBAAAYTbgCAAAwmnAF\nAABgNOEKAADAaMIVAACA0YQrAAAAowlXAAAARhOuAAAAjCZcAQAAGE24AgAAMJpwBQAAYDThCgAA\nwGjCFQAAgNGEKwAAAKMJVwAAAEYTrgAAAIwmXAEAABhNuAIAADCacAUAAGA04QoAAMBowhUAAIDR\nhCsAAACjCVcAAABGE64AAACMJlwBAAAYTbgCAAAwmnAFAABgtBOGa1XdUFUPVdWfbBh7VlXdWlV3\nL5/PXsarqt5RVQer6s6qunjDc65Ytr+7qq54ct4OAAAAO81Wjrj+lySXPW7sQJLbuvvCJLct95Pk\nZUkuXD72J3lncjR0k1yb5EVJXpjk2mOxCwAAAE/khOHa3f8jycOPG748yY3L7RuTvHLD+Lv7qI8k\nOauqzkny0iS3dvfD3f1Iklvz9TEMAAAAX2fPN/i8te5+YLn9YJK15fa5Se7bsN39y9hm41+nqvbn\n6NHarK2tZX19/Ruc4u5yzUVHVj2F08Lamb5XW+VnD1bj8OHDfv6AseyjWJVvNFy/pru7qvpUTGZ5\nveuSXJcke/fu7X379p2ql97Rrjxwy6qncFq45qIjeetd3/Qf+13hntfsW/UUYFdaX1+Pv/uAqeyj\nWJVv9KrCn1+WAGf5/NAyfijJ+Ru2O28Z22wcAAAAntA3Gq43Jzl2ZeArkrx/w/hrl6sLX5Lk0WVJ\n8QeTXFpVZy8XZbp0GQMAAIAndMI1k1X120n2JXl2Vd2fo1cHfkuSm6rqqiT3JnnVsvkHkrw8ycEk\njyV5XZJ098NV9aYkty/bvbG7H3/BJwAAAPg6JwzX7v7xTR56yXG27SRXb/I6NyS54aRmBwAAwK73\njS4VBgAAgG0hXAEAABhNuAIAADCacAUAAGA04QoAAMBowhUAAIDRhCsAAACjCVcAAABGE64AAACM\nJlwBAAAYTbgCAAAwmnAFAABgNOEKAADAaMIVAACA0YQrAAAAowlXAAAARhOuAAAAjCZcAQAAGG3P\nqicAwM53wYFbVj2F08Y1Fx3Jlb5fJ3TPW16x6ikAsI0ccQUAAGA04QoAAMBowhUAAIDRhCsAAACj\nCVcAAABGE64AAACMJlwBAAAYTbgCAAAwmnAFAABgNOEKAADAaMIVAACA0YQrAAAAowlXAAAARhOu\nAAAAjCZcAQAAGE24AgAAMNqeVU8AAABW7YIDt6x6CqeFay46kit9r7bknre8YtVT2FEccQUAAGA0\n4QoAAMBowhUAAIDRhCsAAACjCVcAAABGE64AAACMJlwBAAAYTbgCAAAwmnAFAABgNOEKAADAaMIV\nAACA0YQrAAAAowlXAAAARhOuAAAAjCZcAQAAGE24AgAAMJpwBQAAYDThCgAAwGjCFQAAgNGEKwAA\nAKMJVwAAAEYTrgAAAIwmXAEAABhNuAIAADCacAUAAGA04QoAAMBowhUAAIDRhCsAAACjCVcAAABG\nE64AAACMJlwBAAAYTbgCAAAwmnAFAABgNOEKAADAaMIVAACA0bY9XKvqsqr6bFUdrKoD2/31AQAA\nOL1sa7hW1RlJfi3Jy5I8L8mPV9XztnMOAAAAnF62+4jrC5Mc7O7PdfdXkrwnyeXbPAcAAABOI9sd\nrucmuW/D/fuXMQAAADiu6u7t+2JVP5Lksu7+qeX+TyZ5UXf/zIZt9ifZv9z9ziSf3bYJshs8O8mf\nr3oSAE/AfgqYzD6KU+07uvs5J9poz3bMZINDSc7fcP+8Zexruvu6JNdt56TYParqY929d9XzANiM\n/RQwmX0Uq7LdS4VvT3JhVT23qp6W5NVJbt7mOQAAAHAa2dYjrt19pKp+JskHk5yR5Ibu/tR2zgEA\nAIDTy3YvFU53fyDJB7b768LCMnRgOvspYDL7KFZiWy/OBAAAACdru89xBQAAgJMiXAEAABht289x\nhe1QVf/siR7v7t/drrkAHE9VXfxEj3f3x7drLgCPV1X/+oke7+5f3q65QCJc2bl++Ake6yTCFVi1\ntz7BY53kxds1EYDjeMaqJwAbuTgTAAAAozniyo5keQswnVMaAGDrhCs7leUtwHROaQCALbJUGAAA\ngNEccQWAFXBKA3A6qKrXJ3lXki8m+Y0k35PkQHf/wUonxq7j97gCwGo84wQfABP8i+7+yySXJnlO\nktclectqp8Ru5IgrAKxAd//CqucAsAW1fH55knd19x9XVT3RE+DJ4IgrO1pVvb6qvq2Our6qPl5V\nl656XgAAp4k7quoPcjRcP1hVz0jy/1Y8J3YhF2diR6uqP+7u51fVS5NcneTf5ej/Fl684qkBAIxX\nVU9J8oIkn+vuL1TVs5Kc1913rnhq7DKOuLLTfd3ylg1jAAA8se9N8tklWn8iyb9N8uiK58QuJFzZ\n6SxvAUZzSgMw3DuTPFZVz0/yc0nuTfLu1U6J3Ui4stNdleRAkn/Q3Y8leWqOXg0PYApX7AQmO9JH\nzy28PMnbu/vtceVzVkC4stNZ3gJM55QGYLIvVtUbkvxEkluWc16fuuI5sQsJV3Y6y1uA6ZzSAEz2\nY0m+nOSq7n4wyXlJ/uNqp8Ru5KrC7GhV9fHuvriq/n2SQ919/bGxVc8NIHHFTgDYCkdc2eksbwGm\nc0oDMFZVXVJVt1fV4ar6SlV9tarso9h2wpWdzvIWYDqnNACT/ackP57k7iRnJvmpJL+20hmxK1kq\nDAAr5JQGYLKq+lh3762qO7v77y9jf9jd37fqubG77Fn1BODJVFWXJPnVJH83ydOSnJHkcHc/c6UT\nA/gbG09p+AGnNADDPFZVT0vyyar6D0keSPL0Fc+JXchSYXY6y1uA6ZzSAEz2kzn6H/8/k+RLSc5P\n8s9XOiN2JUuF2dEsbwEAgNOfpcLsdJa3AKM5pQGYqKruSrLpEa5jBwRguzjiyo5WVd+R5KEcPV/s\nXyV5ZpJf7+6DK50YwKKqPpbk1Un+W5K9SV6b5MLu/vmVTgzY1ZZ/Q22qu+/drrlA4ogrO9yGnepf\nJfmFVc4FYDPdfbCqzujuryZ5V1X94arnBOx6T02y1t3/a+NgVf2jJP9nNVNiNxOu7EiWtwCnEac0\nABP9SpLjrfz4q+WxH97e6bDbWSrMjmR5C3C6cEoDMFFV/Ul3/71NHruruy/a7jmxuzniyk5leQtw\nWnBKAzDUtz7BY2du2yxgIVzZqSxvAUZzSgMw3O1V9dPd/Z83DlbVTyW5Y0VzYhezVJgdyfIWYDqn\nNACTVdVakvcl+Ur+JlT35uiv7fqn3f3gqubG7uSIKzuV5S3AdE5pAMbq7s8n+b6q+sEkxw4G3NLd\nH1rhtNjFnrLqCcCT5Paq+unHD1reAgzyK0m+eJzxY6c0AKxcd3+4u391+RCtrIylwuxIlrcA0zml\nAQC2zlJhdiTLW4DTgFMaAGCLHHEFgBWoqt9O8qFNrtj5Q939Y6uZGQDMI1wBYAWc0gAAWydcAWCF\nHndKw6ec0gAAX0+4AgAAMJpfhwMAAMBowhUAAIDRhCsAAACjCVcAAABGE64AAACM9v8Bm6tkXE7P\n6LwAAAAASUVORK5CYII=\n",
"text/plain": [
"<matplotlib.figure.Figure at 0x17b86a8f1d0>"
]
},
"metadata": {},
"output_type": "display_data"
}
],
"source": [
"data.classification.value_counts().plot(kind='bar', grid=True, figsize=(16, 9))"
]
},
{
"cell_type": "code",
"execution_count": 34,
"metadata": {
"collapsed": false
},
"outputs": [
{
"data": {
"text/plain": [
"<matplotlib.axes._subplots.AxesSubplot at 0x17b86ac21d0>"
]
},
"execution_count": 34,
"metadata": {},
"output_type": "execute_result"
},
{
"data": {
"image/png": 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CKwAAAEMTXAEAABia4AoAAMDQBFcAAACGJrgCAAAwNMEVAACAoQmuAAAADE1wBQAAYGiC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\n",
"text/plain": [
"<matplotlib.figure.Figure at 0x17b86af4b00>"
]
},
"metadata": {},
"output_type": "display_data"
}
],
"source": [
"data.country.value_counts().plot(kind='bar', grid=True, figsize=(16, 9))"
]
},
{
"cell_type": "code",
"execution_count": 35,
"metadata": {
"collapsed": true
},
"outputs": [],
"source": [
"# remove duplicate description columns\n",
"data = data.drop_duplicates('product_description')"
]
},
{
"cell_type": "code",
"execution_count": 36,
"metadata": {
"collapsed": true
},
"outputs": [],
"source": [
"# remove rows with empty descriptions\n",
"data = data[~data['product_description'].isnull()]"
]
},
{
"cell_type": "code",
"execution_count": 37,
"metadata": {
"collapsed": false
},
"outputs": [
{
"data": {
"text/plain": [
"(6957, 25)"
]
},
"execution_count": 37,
"metadata": {},
"output_type": "execute_result"
}
],
"source": [
"data.shape"
]
},
{
"cell_type": "code",
"execution_count": 38,
"metadata": {
"collapsed": false
},
"outputs": [],
"source": [
"data['len'] = data['product_description'].map(len)"
]
},
{
"cell_type": "code",
"execution_count": 39,
"metadata": {
"collapsed": false
},
"outputs": [
{
"data": {
"text/plain": [
"(6957, 26)"
]
},
"execution_count": 39,
"metadata": {},
"output_type": "execute_result"
}
],
"source": [
"data.shape"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"### Text processing : tokenization\n",
"[[ go back to the top ]](#Table-of-contents)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Now we start by building a tokenizer. This will, for every description:\n",
"\n",
"- break the descriptions into sentences and then break the sentences into tokens\n",
"- remove punctuation and stop words\n",
"- lowercase the tokens"
]
},
{
"cell_type": "code",
"execution_count": 40,
"metadata": {
"collapsed": false
},
"outputs": [],
"source": [
"def tokenizer(text):\n",
" try:\n",
" tokens_ = [word_tokenize(sent) for sent in sent_tokenize(text)]\n",
" \n",
" tokens = []\n",
" for token_by_sent in tokens_:\n",
" tokens += token_by_sent\n",
"\n",
" tokens = list(filter(lambda t: t.lower() not in stop, tokens))\n",
" tokens = list(filter(lambda t: t not in punctuation, tokens))\n",
" tokens = list(filter(lambda t: t not in [u\"'s\", u\"n't\", u\"...\", u\"''\", u'``', \n",
" u'\\u2014', u'\\u2026', u'\\u2013'], tokens))\n",
" filtered_tokens = []\n",
" for token in tokens:\n",
" if re.search('[a-zA-Z]', token):\n",
" filtered_tokens.append(token)\n",
"\n",
" filtered_tokens = list(map(lambda token: token.lower(), filtered_tokens))\n",
"\n",
" return filtered_tokens\n",
" except Error as e:\n",
" print(e)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"A new column 'tokens' can be easily created using the map method applied to the 'description' column."
]
},
{
"cell_type": "code",
"execution_count": 41,
"metadata": {
"collapsed": false
},
"outputs": [],
"source": [
"data['tokens'] = data['product_description'].map(tokenizer)"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"The tokenizer has been applied to each description through all rows. Each resulting value is then put into the 'tokens' column that is created after the assignment. Let's check what the tokenization looks like for the first 5 descriptions:"
]
},
{
"cell_type": "code",
"execution_count": 42,
"metadata": {
"collapsed": false
},
"outputs": [
{
"name": "stdout",
"output_type": "stream",
"text": [
"product_description: Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA\n",
"tokens: ['imodium', 'multi-symptom', 'relief', 'caplets', 'loperamide', 'hcl', 'mg/simethicone', 'mg', 'count', 'blister', 'pack', 'cartons', 'mcneil', 'consumer', 'healthcare', 'div', 'mcneil-ppc', 'inc.', 'fort', 'washington', 'pa']\n",
"\n",
"product_description: Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.\n",
"tokens: ['magnesium', 'sulfate', 'water', 'injection', 'mg/ml', 'meq', 'mg++/ml', 'g', 'total', 'ml', 'flexible', 'container', 'rx', 'hospira', 'inc.', 'lake', 'forest', 'il', 'ndc']\n",
"\n",
"product_description: Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 \n",
"tokens: ['morphine', 'sulfate', 'extended', 'release', 'tablet', 'mg', 'tablet', 'bottles', 'rx', 'physician', 'total', 'care', 'inc', 'tulsa', 'ok', 'ndc']\n",
"\n",
"product_description: Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9\n",
"tokens: ['dorzolamide', 'hci/timolol', 'maleate', 'ophthalmic', 'solution', '22.3mg/6.8mg', 'per', 'ml', '10ml', 'bottle', 'topical', 'application', 'eye', 'sterile', 'ophthalmic', 'solution', 'rx', 'mfg', 'apotex', 'inc.', 'toronto', 'ontario', 'canada', 'm9l', '1t9']\n",
"\n",
"product_description: Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05\n",
"tokens: ['dr.', 'reddy', 'amlodipine', 'besylate', 'benazepril', 'hydrochloride', 'mg*/20', 'mg', 'capsules', 'rx', 'mfd', 'dr.', 'reddy', 'laboratories', 'limited', 'bachepalli', 'india', 'ndc']\n",
"\n"
]
}
],
"source": [
"for descripition, tokens in zip(data['product_description'].head(5), data['tokens'].head(5)):\n",
" print('product_description:', descripition)\n",
" print('tokens:', tokens)\n",
" print() "
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"Let's group the tokens by category, apply a word count and display the top 10 most frequent tokens. "
]
},
{
"cell_type": "code",
"execution_count": 47,
"metadata": {
"collapsed": false
},
"outputs": [],
"source": [
"def keywords(category):\n",
" tokens = data[data['reason_for_recall'] == category]['tokens']\n",
" alltokens = []\n",
" for token_list in tokens:\n",
" alltokens += token_list\n",
" counter = Counter(alltokens)\n",
" return counter.most_common(10)"
]
},
{
"cell_type": "code",
"execution_count": null,
"metadata": {
"collapsed": false
},
"outputs": [
{
"name": "stdout",
"output_type": "stream",
"text": [
"reason_for_recall : Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.\n",
"top 10 keywords: [('tablets', 1), ('mg', 1), ('buprenorphine', 1), ('upc', 1), ('pharmaceuticals', 1), ('sublingual', 1), ('hydrochloride', 1), ('rx', 1), ('bottles', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.\n",
"top 10 keywords: [('single-dose', 2), ('ndc', 2), ('pharma', 1), ('rx', 1), ('sterile', 1), ('injectable', 1), ('inc.', 1), ('debio', 1), ('triptorelin', 1), ('vial', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014. \n",
"top 10 keywords: [('distributed', 1), ('ndc', 1), ('tablet', 1), ('misoprostol', 1), ('rx', 1), ('mcg', 1), ('service', 1), ('llc', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.\n",
"top 10 keywords: [('fl', 1), ('topical', 1), ('zinc', 1), ('dermallogix', 1), ('otc', 1), ('oz', 1), ('distributed', 1), ('spray', 1), ('pyritione', 1), ('dermazinc', 1)]\n",
"---\n",
"reason_for_recall : Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing. \n",
"top 10 keywords: [('transdermal', 2), ('rx', 1), ('mg/hr', 1), ('use', 1), ('ag', 1), ('lohmann', 1), ('therapie', 1), ('republic', 1), ('germany', 1), ('nitroglycerin', 1)]\n",
"---\n",
"reason_for_recall : Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.\n",
"top 10 keywords: [('code', 4), ('upc', 4), ('lotion', 2), ('sunscreen', 2), ('tube', 2), ('broad', 2), ('canada', 2), ('zinc', 2), ('oxide', 2), ('badger', 2)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications\n",
"top 10 keywords: [('ndc', 19), ('mg', 13), ('manufactured', 13), ('rx', 12), ('tablets', 10), ('nj', 10), ('sun', 9), ('inc.', 8), ('usp', 8), ('upc', 7)]\n",
"---\n",
"reason_for_recall : Resuspension Problems: Recalled lot did not meet resuspendability requirements.\n",
"top 10 keywords: [('ml', 2), ('rx', 1), ('ingelheim', 1), ('laboratories', 1), ('oxcarbazepine', 1), ('ndc', 1), ('suspension', 1), ('oral', 1), ('ohio', 1), ('boehringer', 1)]\n",
"---\n",
"reason_for_recall : Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point\n",
"top 10 keywords: [('ferndale', 4), ('rx', 2), ('cream', 2), ('wt', 2), ('ndc', 2), ('hydrocortisone', 2), ('gm', 2), ('inc.', 2), ('net', 2), ('tubes', 2)]\n",
"---\n",
"reason_for_recall : Superpotent drug: Out of specification test result for assay during stability testing.\n",
"top 10 keywords: [('canada', 3), ('ml', 2), ('amoxicillin', 1), ('rx', 1), ('toronto', 1), ('suspension', 1), ('oral', 1), ('ndc', 1), ('mg/', 1), ('usp', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.\n",
"top 10 keywords: [('fiber', 1), ('30-count', 1), ('mulberry', 1), ('alfalfa', 1), ('sweet', 1), ('distributed', 1), ('leaf', 1), ('aurantium', 1), ('bottle', 1), ('citrus', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container\n",
"top 10 keywords: [('ml', 2), ('rx', 1), ('made', 1), ('inc', 1), ('use', 1), ('valley', 1), ('pharmaceutical', 1), ('spring', 1), ('b', 1), ('bottles', 1)]\n",
"---\n",
"reason_for_recall : Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.\n",
"top 10 keywords: [('novartis', 26), ('tablets', 20), ('stein', 16), ('per', 16), ('pharmaceuticals', 15), ('sale', 13), ('bottle', 13), ('ndc', 13), ('east', 13), ('manufactured', 13)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014; NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 009045\n",
"top 10 keywords: [('distributed', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('llc', 1), ('service', 1), ('counter', 1), ('prenatal', 1), ('multivitamin/multimineral', 1)]\n",
"---\n",
"reason_for_recall : Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A. \n",
"top 10 keywords: [('country', 1), ('b.p.', 1), ('net', 1), ('origin', 1), ('farm', 1), ('new', 1), ('whitfield', 1), ('a1', 1), ('guyana', 1), ('contents', 1)]\n",
"---\n",
"reason_for_recall : The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.\n",
"top 10 keywords: [('pf', 1), ('dexpanthenol', 1), ('pharmacy', 1), ('250mg/ml', 1), ('1ml', 1), ('wellness', 1), ('qty', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, NDC 11523726503, Pedigree: AD42584_15, EXP: 5/14/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('methylprednisolone', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.\n",
"top 10 keywords: [('symptom', 1), ('count', 1), ('blister', 1), ('pe', 1), ('gel', 1), ('liqgel', 1), ('stores', 1), ('distributed', 1), ('hcl', 1), ('acetaminophen/dextromethorphan', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD32582_3, EXP: 5/9/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('bromocriptine', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('mesylate', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Failed pH Specifications: 12 month stability testing\n",
"top 10 keywords: [('hospira', 2), ('inc.', 2), ('il', 1), ('rx', 1), ('use', 1), ('fliptop', 1), ('sulfate', 1), ('rocky', 1), ('forest', 1), ('vial', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. \n",
"top 10 keywords: [('ca', 2), ('ndc', 2), ('bottle', 2), ('inc.', 2), ('tablets', 1), ('stason', 1), ('park', 1), ('rx', 1), ('san', 1), ('60-count', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: W003691, EXP: 6/26/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('mirtazapine', 1)]\n",
"---\n",
"reason_for_recall : Failed Impurities/Degradation Specifications: Out of specifications results for impurities.\n",
"top 10 keywords: [('7-hydrate', 1), ('performance', 1), ('-genar', 1), ('use', 1), ('inc.', 1), ('parkway', 1), ('avantor', 1), ('100lb', 1), ('center', 1), ('corporate', 1)]\n",
"---\n",
"reason_for_recall : Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.\n",
"top 10 keywords: [('tablets', 4), ('carton', 3), ('rx', 2), ('x', 2), ('american', 2), ('inc.', 2), ('ndc', 2), ('oh', 2), ('glenn', 2), ('mercaptopurine', 2)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.\n",
"top 10 keywords: [('ndc', 2), ('ml', 2), ('ny', 1), ('package', 1), ('sodium', 1), ('dose', 1), ('american', 1), ('rx', 1), ('pharmacy', 1), ('regent', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.\n",
"top 10 keywords: [('thinogenics', 2), ('capsules', 2), ('llc', 2), ('p.o', 1), ('bethesda', 1), ('supplement', 1), ('30-count', 1), ('easy', 1), ('box', 1), ('weight', 1)]\n",
"---\n",
"reason_for_recall : Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.\n",
"top 10 keywords: [('tablets', 4), ('rx', 3), ('100-count', 3), ('ii', 3), ('llc.', 3), ('sulfate', 3), ('ndc', 3), ('hyoscyamine', 3), ('tn', 3), ('mg', 3)]\n",
"---\n",
"reason_for_recall : Failed Impuities/Degradation Specifications\n",
"top 10 keywords: [('fresenius', 2), ('base', 2), ('dose', 2), ('/ml', 2), ('mg/ml', 2), ('rx', 2), ('kabi', 2), ('mcg', 2), ('schaumburg', 2), ('ndc', 2)]\n",
"---\n",
"reason_for_recall : Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements. \n",
"top 10 keywords: [('country', 1), ('remedy', 1), ('net', 1), ('origin', 1), ('rector', 1), ('farm', 1), ('new', 1), ('a1', 1), ('guyana', 1), ('contents', 1)]\n",
"---\n",
"reason_for_recall : CGMP Deviations: Product excipient was not re-tested at the appropriate date.\n",
"top 10 keywords: [('ndc', 3), ('ml', 3), ('bottles', 2), ('corp.', 1), ('rx', 1), ('apotex', 1), ('bromfenac', 1), ('available', 1), ('b', 1), ('weston', 1)]\n",
"---\n",
"reason_for_recall : First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).\n",
"top 10 keywords: [('boxes', 2), ('aid', 2), ('first', 2), ('smart', 1), ('tab', 1), ('count', 1), ('wa', 1), ('ibuprofen', 1), ('ezrefill', 1), ('inc.', 1)]\n",
"---\n",
"reason_for_recall : Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.\n",
"top 10 keywords: [('reumofan', 3), ('plus', 2), ('llc', 2), ('usa', 2), ('tablets', 1), ('distriubted', 1), ('30-count', 1), ('per', 1), ('natural', 1), ('riger', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('darunavir', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.\n",
"top 10 keywords: [('mg/0.025', 3), ('mg', 3), ('tablets', 2), ('ca', 2), ('inc.', 2), ('ndc', 2), ('watson', 2), ('per', 2), ('corona', 2), ('rx', 1)]\n",
"---\n",
"reason_for_recall : Subpotency: product assayed and found OOS for cyproheptadine\n",
"top 10 keywords: [('inc.', 2), ('ml', 2), ('rx', 1), ('nj', 1), ('pint', 1), ('laboratories', 1), ('one', 1), ('glass', 1), ('distributed', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.\n",
"top 10 keywords: [('ltd.', 2), ('pharmaceutical', 2), ('rx', 1), ('india', 1), ('elijah', 1), ('ketorolac', 1), ('distributed', 1), ('ndc', 1), ('highway', 1), ('mi', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as the following drug: MERCapsuleTOPURINE, Tablet, 50 mg, NDC 00054458111, Pedigree: AD54549_1, EXP: 5/20/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('sodium', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('fosinopril', 1), ('ndc', 1), ('llc', 1), ('service', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. \n",
"top 10 keywords: [('tablet', 4), ('rx', 2), ('ok', 2), ('care', 2), ('tulsa', 2), ('morphine', 2), ('physician', 2), ('bottles', 2), ('total', 2), ('inc', 2)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('dr', 1), ('tablet', 1), ('acid', 1), ('distributed', 1), ('mycophenolic', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.\n",
"top 10 keywords: [('heparin', 3), ('sodium', 2), ('usp', 2), ('ml', 2), ('il', 1), ('rx', 1), ('unit', 1), ('ndc', 1), ('units/ml', 1), ('flexible', 1)]\n",
"---\n",
"reason_for_recall : Failed Tablet Specifications: Broken Tablets Present.\n",
"top 10 keywords: [('tablets', 2), ('oxcarbazepine', 2), ('distributed', 2), ('dispense', 2), ('pharmaceutical', 2), ('caraco', 2), ('detroit', 2), ('tablet', 2), ('rx', 2), ('ltd.', 2)]\n",
"---\n",
"reason_for_recall : Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.\n",
"top 10 keywords: [('tablets', 2), ('ca', 2), ('distributed', 2), ('laboratorios', 2), ('upc', 2), ('san', 2), ('co.', 2), ('diego', 2), ('pentrexcilina', 2), ('fl', 1)]\n",
"---\n",
"reason_for_recall : Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.\n",
"top 10 keywords: [('new', 12), ('york', 12), ('clinique', 12), ('fl', 6), ('oz.liq./30', 6), ('surge', 6), ('moisturizer', 6), ('tinted', 6), ('dist', 6), ('london', 6)]\n",
"---\n",
"reason_for_recall : Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume\n",
"top 10 keywords: [('ml', 2), ('fl', 1), ('supplied', 1), ('unit', 1), ('125mg/', 1), ('inc.', 1), ('largo', 1), ('xactdose', 1), ('suspension', 1), ('oral', 1)]\n",
"---\n",
"reason_for_recall : Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.\n",
"top 10 keywords: [('mg', 2), ('triangle', 2), ('nc', 2), ('research', 2), ('park', 2), ('tablets', 1), ('viiv', 1), ('300mg', 1), ('lamivudine', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.\n",
"top 10 keywords: [('il', 1), ('rx', 1), ('marketed', 1), ('lipase', 1), ('pancrelipase', 1), ('north', 1), ('inc.', 1), ('product', 1), ('delayed-release', 1), ('germany', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014. \n",
"top 10 keywords: [('mg', 1), ('distributed', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('rx', 1), ('llc', 1), ('service', 1), ('leflunomide', 1)]\n",
"---\n",
"reason_for_recall : Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.\n",
"top 10 keywords: [('canada', 3), ('ml', 3), ('ndc', 2), ('teva', 2), ('bottle', 2), ('manufactured', 2), ('amoxicillin', 1), ('rx', 1), ('toronto', 1), ('m1b2k9', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentially mislabeled as ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: AD22858_1, EXP: 3/31/2014.\n",
"top 10 keywords: [('mg', 1), ('aidapak', 1), ('w/fluoride', 1), ('f', 1), ('counter', 1), ('multivitamin/multimineral', 1), ('distributed', 1), ('ndc', 1), ('chew', 1), ('tablet', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg\t, NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL\n",
"top 10 keywords: [('duloxetine', 1), ('mg', 1), ('ndc', 1), ('hcl', 1), ('aidapak', 1), ('dr', 1), ('rx', 1), ('distributed', 1), ('llc', 1), ('service', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg \n",
"top 10 keywords: [('ciprofloxacin', 1), ('mg', 1), ('tablets', 1), ('count', 1), ('unique', 1), ('rx', 1), ('pharmacecuticals', 1), ('pharmaceutical', 1), ('mumbai', 1), ('india', 1)]\n",
"---\n",
"reason_for_recall : Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point\n",
"top 10 keywords: [('rx', 1), ('solution', 1), ('columbus', 1), ('oral', 1), ('ndc', 1), ('ohio', 1), ('roxane', 1), ('bottle', 1), ('laboratories', 1), ('mcg/ml', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes\n",
"top 10 keywords: [('deerfield', 1), ('il', 1), ('sodium', 1), ('healthcare', 1), ('plastic', 1), ('injection', 1), ('baxter', 1), ('usp', 1), ('chloride', 1), ('container', 1)]\n",
"---\n",
"reason_for_recall : Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.\n",
"top 10 keywords: [('canada', 6), ('dental', 3), ('c', 2), ('dist', 2), ('inc.', 2), ('made', 2), ('pharmaceutical', 2), ('n1r6x3', 2), ('ontario', 2), ('novocol', 2)]\n",
"---\n",
"reason_for_recall : Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil\n",
"top 10 keywords: [('72hp', 2), ('blister', 1), ('fl', 1), ('potency', 1), ('enhancement', 1), ('per', 1), ('inc.', 1), ('pack', 1), ('weston', 1), ('distributed', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: AD42592_4, EXP: 5/14/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('omeprazole/sodium', 1), ('aidapak', 1), ('distributed', 1), ('mg/110', 1), ('llc', 1), ('service', 1), ('capsule', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.\n",
"top 10 keywords: [('mg', 6), ('rx', 3), ('memantine', 3), ('extended', 3), ('louis', 3), ('ndc', 3), ('hcl', 3), ('pack', 3), ('forest', 3), ('mo', 3)]\n",
"---\n",
"reason_for_recall : Superpotent Drug: one ingredient was found to be above assay specification.\n",
"top 10 keywords: [('mg', 3), ('rx', 1), ('papaverine', 1), ('polaris', 1), ('las', 1), ('ave.', 1), ('inc.', 1), ('vials', 1), ('pge', 1), ('injection', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014.\n",
"top 10 keywords: [('mg', 1), ('distributed', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('rx', 1), ('sulfasalazine', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. \n",
"top 10 keywords: [('pharmaceuticals', 2), ('canada', 2), ('ml', 2), ('manufactured', 2), ('rx', 1), ('contract', 1), ('limited', 1), ('sellersville', 1), ('ndc', 1), ('sulfate', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.\n",
"top 10 keywords: [('el', 2), ('tablets', 1), ('huesos', 1), ('nueva', 1), ('presentacion', 1), ('en', 1), ('otc', 1), ('cancer', 1), ('original', 1), ('previene', 1)]\n",
"---\n",
"reason_for_recall : CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.\n",
"top 10 keywords: [('count', 8), ('bottles', 8), ('ndc', 8), ('tablets', 4), ('mg', 4), ('rx', 4), ('new', 4), ('nationwide', 4), ('usp', 4), ('iselin', 4)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; ASCORBIC ACID Tablet, 500 mg may be potentially mislabeled as FEBUXOSTAT, Tablet, 40 mg, NDC 64764091830, Pedigree: AD23082_16, EXP: 11/1/2013.\n",
"top 10 keywords: [('mg', 1), ('ascorbic', 1), ('ndc', 1), ('tablet', 1), ('acid', 1), ('distributed', 1), ('service', 1), ('counter', 1), ('llc', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.\n",
"top 10 keywords: [('mg', 2), ('rx', 1), ('ndc', 1), ('hcl', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('tizanidine', 1)]\n",
"---\n",
"reason_for_recall : Subpotent Drug: menthol and methyl salicylate below specification\n",
"top 10 keywords: [('west', 2), ('tx', 2), ('company', 2), ('pharmacal', 2), ('mission', 2), ('ih', 2), ('boerne', 1), ('relieving', 1), ('thera-gesic', 1), ('back', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.\n",
"top 10 keywords: [('mg', 1), ('aidapak', 1), ('distributed', 1), ('acetaminophen/', 1), ('mg/65', 1), ('counter', 1), ('mg/250', 1), ('ndc', 1), ('tablet', 1), ('caffeine', 1)]\n",
"---\n",
"reason_for_recall : SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.\n",
"top 10 keywords: [('tablets', 2), ('ndc', 2), ('packaged', 2), ('mg', 1), ('100-count', 1), ('count', 1), ('rx', 1), ('oxcarbazepine', 1), ('inc.', 1), ('blisters', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: all sterile compounded products within expiry \n",
"top 10 keywords: [('westlake', 10), ('rx', 5), ('ca', 5), ('park', 5), ('compounding', 5), ('pharmacy', 5), ('n.', 5), ('blvd.', 5), ('vial', 5), ('village', 5)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.\n",
"top 10 keywords: [('ml', 263), ('ndc', 140), ('code', 129), ('service', 129), ('bag', 101), ('hcl', 87), ('free', 76), ('compounded', 75), ('pharmedium', 75), ('tn', 75)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.\n",
"top 10 keywords: [('pharmacy', 2), ('dallas', 2), ('tx', 2), ('nuvision', 2), ('vial', 2), ('stock', 2), ('compounded', 2), ('ml', 2), ('mg', 1), ('sermorelin/ghrp-6', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement\n",
"top 10 keywords: [('capsules', 2), ('bottle', 1), ('supplied', 1), ('burn', 1)]\n",
"---\n",
"reason_for_recall : Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin \n",
"top 10 keywords: [('tablets', 1), ('mg', 1), ('supplement', 1), ('arthmax', 1), ('foundation', 1), ('los', 1), ('human', 1), ('bottles', 1), ('distributed', 1), ('count', 1)]\n",
"---\n",
"reason_for_recall : Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.\n",
"top 10 keywords: [('tablets', 2), ('manufactured', 2), ('mg', 1), ('fl', 1), ('ltd.', 1), ('per', 1), ('rx', 1), ('india', 1), ('meloxicam', 1), ('corp.', 1)]\n",
"---\n",
"reason_for_recall : Presence of Precipitate; precipitation of drug product\n",
"top 10 keywords: [('ndc', 4), ('vial', 3), ('carton', 2), ('ml', 2), ('rx', 1), ('ca', 1), ('mg/ml', 1), ('irvine', 1), ('use', 1), ('iv', 1)]\n",
"---\n",
"reason_for_recall : Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles. \n",
"top 10 keywords: [('packaged', 12), ('individually', 6), ('ldpe', 6), ('seal', 6), ('filled', 6), ('ophthalmic', 6), ('equipped', 6), ('dropper', 6), ('tip', 6), ('polyethylene', 6)]\n",
"---\n",
"reason_for_recall : Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil\n",
"top 10 keywords: [('natural', 2), ('blister', 1), ('distribution', 1), ('supplied', 1), ('power', 1), ('max', 1), ('llc', 1), ('pack', 1), ('herbs', 1), ('distributed', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.\n",
"top 10 keywords: [('ml', 191), ('mesa', 77), ('drugs', 77), ('including', 77), ('henderson', 77), ('injection', 77), ('green', 77), ('valley', 77), ('whitney', 77), ('rx', 77)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the following drugs: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, NDC 11523726503, Pedigree: AD70655_20, EXP: 5/29/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 37205098769, Pedigree: AD73623_7, EXP: 5/30/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W002697, EXP: 6/5/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('thyroid', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory\n",
"top 10 keywords: [('ok', 1), ('mg/ml', 1), ('sterile', 1), ('injectable', 1), ('tulsa', 1), ('apothecary', 1), ('cypionate', 1), ('st.', 1), ('51st', 1), ('sih-testosterone', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.\n",
"top 10 keywords: [('ml', 2), ('il', 1), ('rx', 1), ('mg/ml', 1), ('sterile', 1), ('ndc', 1), ('ondansetron', 1), ('mg/2', 1), ('injection', 1), ('usp', 1)]\n",
"---\n",
"reason_for_recall : Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.\n",
"top 10 keywords: [('ml', 4), ('valley', 3), ('drugs', 3), ('green', 3), ('use', 2), ('vials', 2), ('nv', 2), ('henderson', 2), ('office', 2), ('manufactured', 2)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.\n",
"top 10 keywords: [('pharmaceuticals', 1), ('cherry', 1), ('18-count', 1), ('vapor', 1), ('insight', 1), ('throat', 1), ('sore', 1), ('pa', 1), ('dist', 1), ('tin', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003789, EXP: 6/27/2014; prednisoLONE, Tablet, 5 mg, NDC 16477050501, Pedigree: W003627, EXP: 6/25/2014. \n",
"top 10 keywords: [('ndc', 1), ('distributed', 1), ('complex', 1), ('tablet', 1), ('aidapak', 1), ('vitamin', 1), ('service', 1), ('counter', 1), ('llc', 1), ('b', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg\n",
"top 10 keywords: [('tablets', 2), ('trimethoprim', 2), ('mg', 2), ('sulfamethoxazole', 2), ('rx', 1), ('center', 1), ('mg/160', 1), ('mg/80', 1), ('repackaged', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as the following drug: ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD25264_1, EXP: 5/3/2014. \n",
"top 10 keywords: [('mg', 1), ('mexiletine', 1), ('ndc', 1), ('hcl', 1), ('aidapak', 1), ('rx', 1), ('distributed', 1), ('llc', 1), ('service', 1), ('capsule', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.\n",
"top 10 keywords: [('ct', 2), ('sandoz', 2), ('ndc', 2), ('manufactured', 2), ('amoxicillin', 1), ('mg', 1), ('princeton', 1), ('rx', 1), ('nj', 1), ('bottles', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.\n",
"top 10 keywords: [('vial', 2), ('il', 1), ('rx', 1), ('sodium', 1), ('lake', 1), ('per', 1), ('inc.', 1), ('ndc', 1), ('fliptop', 1), ('injection', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. \n",
"top 10 keywords: [('ml', 824), ('injectable', 226), ('vial', 141), ('mls', 83), ('kit', 83), ('p.f', 75), ('products', 73), ('different', 72), ('ophthalmic', 63), ('syringe', 49)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033\n",
"top 10 keywords: [('mg', 1), ('fl', 1), ('labs', 1), ('lauderdale', 1), ('lgd-4033', 1), ('ligandrol', 1), ('fort', 1), ('capsules', 1), ('lgd-xtreme', 1), ('bottle', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.\n",
"top 10 keywords: [('capsules', 6), ('bottles', 5), ('manufactured', 4), ('mg', 4), ('30-count', 3), ('floyd', 2), ('pharmaceuticals', 2), ('nutrition', 2), ('60-count', 2), ('zi', 2)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.\n",
"top 10 keywords: [('distributed', 4), ('florida', 3), ('fl', 2), ('day', 2), ('x-rock', 2), ('blister', 2), ('pill', 2), ('upc', 2), ('capsule', 2), ('labeled', 2)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.\n",
"top 10 keywords: [('capsules', 3), ('packaged', 3), ('inc.', 2), ('il', 1), ('blister', 1), ('30-count', 1), ('coated', 1), ('rx', 1), ('box', 1), ('udl', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.\n",
"top 10 keywords: [('rx', 6), ('capsules', 6), ('loxapine', 5), ('count', 5), ('ca', 5), ('inc.', 5), ('ndc', 5), ('corona', 5), ('laboratories', 5), ('bottle', 5)]\n",
"---\n",
"reason_for_recall : Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.\n",
"top 10 keywords: [('per', 2), ('bromide', 1), ('ct', 1), ('ipratropium', 1), ('ingelheim', 1), ('mcg/100', 1), ('inhaler', 1), ('mcg', 1), ('respimat', 1), ('rx', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.\n",
"top 10 keywords: [('tablets', 1), ('rx', 1), ('horsham', 1), ('box', 1), ('extended', 1), ('rd', 1), ('ud-100', 1), ('ndc', 1), ('pa', 1), ('teva', 1)]\n",
"---\n",
"reason_for_recall : Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.\n",
"top 10 keywords: [('glenmark', 3), ('generics', 2), ('manufactured', 2), ('mg', 1), ('tablets', 1), ('sodium', 1), ('ltd', 1), ('nj', 1), ('rx', 1), ('bardez', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014. \n",
"top 10 keywords: [('mg', 1), ('distributed', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('rx', 1), ('varenicline', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('benzocaine/menthol', 1), ('lozenge', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('mg/3.6', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('itraconazole', 1), ('aidapak', 1), ('distributed', 1), ('llc', 1), ('service', 1), ('capsule', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).\n",
"top 10 keywords: [('bottle', 3), ('ml', 3), ('b', 2), ('c', 2), ('ophthalmic', 2), ('ciprofloxacin', 1), ('base', 1), ('pharmacal', 1), ('topical', 1), ('sterile', 1)]\n",
"---\n",
"reason_for_recall : Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.\n",
"top 10 keywords: [('rx', 1), ('pharmacal', 1), ('acid', 1), ('upc', 1), ('co.', 1), ('inc.', 1), ('acetic', 1), ('ndc', 1), ('usp', 1), ('ml', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. \n",
"top 10 keywords: [('fl', 1), ('ying', 1), ('co.', 1), ('liquid', 1), ('oz', 1), ('herbs', 1), ('distributed', 1), ('ndc', 1), ('wuhan', 1), ('guaifenesin', 1)]\n",
"---\n",
"reason_for_recall : Chemical contamination: emission of strong odor after package was opened.\n",
"top 10 keywords: [('bottles', 14), ('ndc', 14), ('tablets', 7), ('rx', 7), ('sodium', 7), ('tn', 7), ('bristol', 7), ('pharmaceuticals', 7), ('mcg', 7), ('b', 7)]\n",
"---\n",
"reason_for_recall : Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.\n",
"top 10 keywords: [('kg', 463), ('pharmaceuticals', 463), ('unit', 463), ('packaged', 463), ('bags', 463), ('attix', 463), ('street', 463), ('varying', 463), ('drums', 463), ('pharmaceutical', 463)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6\n",
"top 10 keywords: [('mg', 1), ('er', 1), ('lithium', 1), ('carbonate', 1), ('tablet', 1), ('aidapak', 1), ('rx', 1), ('distributed', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Failed Content Uniformity Specifications: out of specification test result for spray content uniformity. \n",
"top 10 keywords: [('mcg', 2), ('per', 2), ('northridge', 1), ('rx', 1), ('nasal', 1), ('children', 1), ('ca', 1), ('horsham', 1), ('aerosol', 1), ('dipropionate', 1)]\n",
"---\n",
"reason_for_recall : Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.\n",
"top 10 keywords: [('il', 1), ('rx', 1), ('mg*/vial', 1), ('mfd', 1), ('forest', 1), ('ndc', 1), ('rifampin', 1), ('injection', 1), ('usp', 1), ('akorn', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('cidofovir', 1), ('mg/ml', 1), ('upc', 1), ('inc.', 1), ('ca', 1), ('ndc', 1), ('vistide', 1), ('injection', 1)]\n",
"---\n",
"reason_for_recall : Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.\n",
"top 10 keywords: [('il', 1), ('rx', 1), ('ringer', 1), ('ndc', 1), ('lake', 1), ('flexible', 1), ('hospira', 1), ('injection', 1), ('containers', 1), ('usp', 1)]\n",
"---\n",
"reason_for_recall : Stability data does not support expiry. \n",
"top 10 keywords: [('pharmakon', 20), ('injectable', 20), ('inc', 20), ('pharmaceuticals', 20), ('rx', 20), ('packed', 20), ('syringes', 20), ('mg/ml', 17), ('dosage', 15), ('total', 15)]\n",
"---\n",
"reason_for_recall : Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.\n",
"top 10 keywords: [('ml', 2), ('manufactured', 2), ('reddy', 1), ('rx', 1), ('vials', 1), ('pithampur', 1), ('cipla', 1), ('plot', 1), ('sez', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.\n",
"top 10 keywords: [('capsules', 2), ('drug', 1), ('mg', 1), ('manufactory', 1), ('mayhem', 1), ('proprietary', 1), ('upc', 1), ('chaotic-labz', 1), ('product', 1), ('bottles', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution: Out of Specification test results (low) at the 18 month time-point.\n",
"top 10 keywords: [('czech', 3), ('tablets', 2), ('republic', 2), ('teva', 2), ('manufactured', 2), ('mg', 1), ('per', 1), ('rx', 1), ('sellersville', 1), ('pa', 1)]\n",
"---\n",
"reason_for_recall : Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.\n",
"top 10 keywords: [('tablets', 2), ('mg', 1), ('hydroxychloroquine', 1), ('per', 1), ('princeton', 1), ('rx', 1), ('sandoz', 1), ('nj', 1), ('sulfate', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD49426_1, EXP: 5/16/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('llc', 1), ('service', 1), ('quetiapine', 1), ('fumarate', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014. \n",
"top 10 keywords: [('distributed', 1), ('acidophilus', 1), ('ndc', 1), ('aidapak', 1), ('llc', 1), ('cfu', 1), ('lactobacillus', 1), ('million', 1), ('counter', 1), ('capsule', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry). \n",
"top 10 keywords: [('mg', 1), ('tablets', 1), ('x', 1), ('civ', 1), ('princeton', 1), ('rx', 1), ('sandoz', 1), ('inc.', 1), ('nj', 1), ('cards', 1)]\n",
"---\n",
"reason_for_recall : CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.\n",
"top 10 keywords: [('wockhardt', 4), ('usa', 4), ('tablets', 2), ('mg', 2), ('upc', 2), ('rx', 2), ('llc', 2), ('nj', 2), ('lisinopril', 2), ('blvd', 2)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('hyoscyamine', 1), ('tablet', 1), ('sl', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 500 mg, NDC 60258014101, Pedigree: AD23082_19, EXP: 5/6/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002666, EXP: 6/5/2014. \n",
"top 10 keywords: [('distributed', 1), ('ndc', 1), ('aidapak', 1), ('rx', 1), ('mcg', 1), ('service', 1), ('capsule', 1), ('llc', 1), ('paricalcitol', 1)]\n",
"---\n",
"reason_for_recall : Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. \n",
"top 10 keywords: [('israel', 6), ('capsules', 6), ('teva', 6), ('manufactured', 6), ('mg', 3), ('rx', 3), ('ltd', 3), ('per', 3), ('pharmaceuticals', 3), ('pharmaceutical', 3)]\n",
"---\n",
"reason_for_recall : Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.\n",
"top 10 keywords: [('inc.', 2), ('tablets', 1), ('rx', 1), ('count', 1), ('ca', 1), ('pharma', 1), ('pharmaceuticals', 1), ('al', 1), ('irvine', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.\n",
"top 10 keywords: [('ciprofloxacin', 1), ('tablets', 1), ('100-count', 1), ('hikma', 1), ('jordan', 1), ('rx', 1), ('pharmaceutical', 1), ('nj', 1), ('corp.', 1), ('mg', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.\n",
"top 10 keywords: [('tablets', 2), ('mg', 1), ('blister', 1), ('wyeth', 1), ('rx', 1), ('mg/5.0', 1), ('containing', 1), ('ndc', 1), ('acetate', 1), ('card', 1)]\n",
"---\n",
"reason_for_recall : Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.\n",
"top 10 keywords: [('rx', 18), ('pharmacy', 17), ('park', 17), ('drug', 17), ('overland', 17), ('compounding', 17), ('perry', 17), ('ks', 17), ('compounded', 16), ('ndc', 14)]\n",
"---\n",
"reason_for_recall : Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.\n",
"top 10 keywords: [('mg', 1), ('er', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('dinitrate', 1), ('distributed', 1), ('isosorbide', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; DOXYCYCLINE HYCLATE, Tablet, 100 mg may be potentially mislabeled as DESLORATADINE, Tablet, 5 mg, NDC 00085126401, Pedigree: AD30993_5, EXP: 2/28/2014.\n",
"top 10 keywords: [('mg', 1), ('doxycycline', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('rx', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('hyclate', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point\n",
"top 10 keywords: [('phenobarbital', 1), ('tablets', 1), ('mfd', 1), ('rx', 1), ('pharmaceutical', 1), ('nj', 1), ('corp.', 1), ('bottles', 1), ('100=count', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Chemical contamination: Product may be contaminated with a toxic compound.\n",
"top 10 keywords: [('per', 4), ('fl', 2), ('ml', 2), ('pouches', 2), ('upc', 2), ('iodine', 2), ('w/urethane', 2), ('single', 2), ('packaged', 2), ('use', 2)]\n",
"---\n",
"reason_for_recall : Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.\n",
"top 10 keywords: [('il', 1), ('rx', 1), ('non-pyrogenic', 1), ('mg/ml', 1), ('sterile', 1), ('diazepam', 1), ('inc.', 1), ('ndc', 1), ('fliptop', 1), ('injection', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014. \n",
"top 10 keywords: [('distributed', 1), ('ndc', 1), ('aidapak', 1), ('rx', 1), ('mcg', 1), ('service', 1), ('capsule', 1), ('llc', 1), ('lubiprostone', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: All compounded products.\n",
"top 10 keywords: [('compounded', 1), ('sterile', 1), ('drugs', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.\n",
"top 10 keywords: [('rx', 42), ('discard', 41), ('fl', 30), ('trinity', 30), ('202-c', 30), ('17th', 30), ('care', 30), ('street', 30), ('sw', 30), ('solutions', 30)]\n",
"---\n",
"reason_for_recall : Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)\n",
"top 10 keywords: [('ml', 2), ('corp.', 1), ('rx', 1), ('eatontown', 1), ('pharma', 1), ('vials', 1), ('lenoir', 1), ('ndc', 1), ('exela', 1), ('injection', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.\n",
"top 10 keywords: [('il', 1), ('rx', 1), ('mg/ml', 1), ('forest', 1), ('teartop', 1), ('inc.', 1), ('vials', 1), ('ndc', 1), ('lidocaine', 1), ('injection', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.\n",
"top 10 keywords: [('tablets', 1), ('mg', 1), ('count', 1), ('pharmaceuticals', 1), ('tarceva', 1), ('rx', 1), ('seymour', 1), ('ndc', 1), ('erlotinib', 1), ('bottle', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.\n",
"top 10 keywords: [('vials', 2), ('single-use', 2), ('free', 2), ('fl', 1), ('preservative', 1), ('oz', 1), ('tears', 1), ('60-count', 1), ('dextran', 1), ('drops', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('sodium', 1), ('dr', 1), ('tablet', 1), ('aidapak', 1), ('pantoprazole', 1), ('distributed', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.\n",
"top 10 keywords: [('pf', 2), ('az', 2), ('pharmacy', 2), ('specialty', 2), ('avella', 2), ('ml', 2), ('phoenix', 2), ('bevacizumab', 1), ('vancomycin', 1), ('mg/0.05', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: glass delamination\n",
"top 10 keywords: [('total', 1), ('units/ml', 1), ('care', 1), ('oaks', 1), ('dist', 1), ('tulsa', 1), ('alfa', 1), ('epoetin', 1), ('physicians', 1), ('ok', 1)]\n",
"---\n",
"reason_for_recall : Failed Stability Specifications\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('count', 1), ('pharmaceuticals', 1), ('temazepam', 1), ('qualitest', 1), ('bottles', 1), ('ndc', 1), ('usp', 1), ('capsules', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: OXcarbazepine, Tablet, 150 mg, NDC 62756018388, Pedigree: AD54562_4, EXP: 5/20/2014. \n",
"top 10 keywords: [('mg', 1), ('ascorbic', 1), ('ndc', 1), ('tablet', 1), ('acid', 1), ('distributed', 1), ('service', 1), ('counter', 1), ('llc', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, ND\n",
"top 10 keywords: [('mg', 1), ('distributed', 1), ('ndc', 1), ('tablet', 1), ('caffeine', 1), ('service', 1), ('counter', 1), ('llc', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('hcl', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('fexofenadine', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 50 mg may have potentially been mislabeled as the following drug: SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W002979, EXP: 6/11/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('chlorthalidone', 1)]\n",
"---\n",
"reason_for_recall : Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.\n",
"top 10 keywords: [('tablets', 2), ('rx', 1), ('per', 1), ('ingelheim', 1), ('perindopril', 1), ('columbus', 1), ('ndc', 1), ('boehringer', 1), ('roxane', 1), ('oh', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.\n",
"top 10 keywords: [('il', 1), ('injection', 1), ('hcl', 1), ('usp', 1), ('mg/ml', 1), ('forest', 1), ('hospira', 1), ('lake', 1), ('inc.', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot. \n",
"top 10 keywords: [('diluent', 2), ('inc.', 2), ('usa', 2), ('ndc', 2), ('manufactured', 2), ('bicnu', 2), ('luitpold', 1), ('rx', 1), ('nj', 1), ('shirley', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.\n",
"top 10 keywords: [('count', 8), ('mg', 3), ('blister', 3), ('box', 3), ('packaged', 3), ('packs', 3), ('capsules', 2), ('www.hotrodextrastrength.com', 1), ('extra', 1), ('www.firminite.com', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.\n",
"top 10 keywords: [('best', 2), ('mg', 1), ('clemente', 1), ('red', 1), ('ca', 1), ('upc', 1), ('san', 1), ('doctor', 1), ('rice', 1), ('capsules', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP\n",
"top 10 keywords: [('hi-tech', 2), ('pharmacal', 2), ('propionate', 1), ('rx', 1), ('use', 1), ('cream', 1), ('ndc', 1), ('label', 1), ('ny', 1), ('inc.', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. \n",
"top 10 keywords: [('suite', 5), ('one', 5), ('fentanyl', 5), ('park', 5), ('west', 5), ('use', 5), ('prohibits', 5), ('prescription', 5), ('ndc', 5), ('mcg/ml', 5)]\n",
"---\n",
"reason_for_recall : Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.\n",
"top 10 keywords: [('tablets', 2), ('blister', 2), ('ndc', 2), ('per', 2), ('manufactured', 2), ('mg', 1), ('mg/0.1', 1), ('rx', 1), ('sellersville', 1), ('barr', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('hcl', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('propranolol', 1), ('llc', 1), ('service', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning\n",
"top 10 keywords: [('malta', 2), ('tablets', 1), ('mg', 1), ('count', 1), ('ltd.', 1), ('losartan', 1), ('rx', 1), ('ca', 1), ('gsms', 1), ('bizebbugia', 1)]\n",
"---\n",
"reason_for_recall : Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint. \n",
"top 10 keywords: [('fl', 2), ('rugby', 2), ('cherry', 2), ('oz', 2), ('distributed', 2), ('ndc', 2), ('children', 2), ('bottle', 2), ('major', 2), ('livonia', 2)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('colchicine', 1)]\n",
"---\n",
"reason_for_recall : FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. \n",
"top 10 keywords: [('ny', 4), ('mg', 2), ('pregabalin', 2), ('rx', 2), ('pfizer', 2), ('division', 2), ('lyrica', 2), ('parke-davis', 2), ('distributed', 2), ('ndc', 2)]\n",
"---\n",
"reason_for_recall : Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.\n",
"top 10 keywords: [('pharmacy', 3), ('ndc', 3), ('aid', 3), ('antiseptic', 2), ('first', 2), ('minor', 1), ('relieves', 1), ('itching', 1), ('anesthetic', 1), ('c', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD46265_49, EXP: 5/15/2014; MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD60240_14, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002693, EXP: 6/5/2014; GLUCOSAMIN\n",
"top 10 keywords: [('niacin', 1), ('mg', 1), ('ndc', 1), ('aidapak', 1), ('rx', 1), ('distributed', 1), ('llc', 1), ('service', 1), ('capsule', 1), ('tr', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.\n",
"top 10 keywords: [('blvd', 1), ('nanowellbeing', 1), ('supplement', 1), ('ca', 1), ('upc', 1), ('mirada', 1), ('inc.', 1), ('arthgold', 1), ('super', 1), ('5v', 1)]\n",
"---\n",
"reason_for_recall : CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. \n",
"top 10 keywords: [('tetrahydrozoline', 1), ('corp.', 1), ('ca', 1), ('gardena', 1), ('yy1568', 1), ('cat', 1), ('hydrochloride', 1), ('usp', 1), ('bottle', 1), ('mfg', 1)]\n",
"---\n",
"reason_for_recall : Lack of Assurance of Sterility - the firm is recalling select sterile drug products.\n",
"top 10 keywords: [('cantrell', 42), ('ml', 23), ('little', 21), ('drug', 21), ('rx', 21), ('ar', 21), ('ndc', 19), ('single-dose', 19), ('rock', 18), ('chloride', 18)]\n",
"---\n",
"reason_for_recall : Labeling: Wrong Bar Code\n",
"top 10 keywords: [('ndc', 2), ('panel', 2), ('tablets', 1), ('rx', 1), ('bellmawr', 1), ('top', 1), ('hyclate', 1), ('distributed', 1), ('dorado', 1), ('bottle', 1)]\n",
"---\n",
"reason_for_recall : Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride. \n",
"top 10 keywords: [('bags', 3), ('lb', 3), ('morton', 2), ('drums', 2), ('semi-bulk', 2), ('sodium', 1), ('product', 1), ('inc.', 1), ('salt', 1), ('fiber', 1)]\n",
"---\n",
"reason_for_recall : Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.\n",
"top 10 keywords: [('mg', 4), ('usp', 4), ('tablets', 3), ('sulfate', 2), ('ndc', 2), ('bottle', 2), ('per', 2), ('phenobarbital', 1), ('scopolamine', 1), ('eatontown', 1)]\n",
"---\n",
"reason_for_recall : Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&amp;2)\n",
"top 10 keywords: [('mg', 2), ('count', 2), ('cetirizine', 2), ('ndc', 2), ('hcl', 2), ('major', 2), ('blister', 2), ('sandoz', 2), ('pack', 2), ('children', 2)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. \n",
"top 10 keywords: [('ml', 2), ('il', 1), ('rx', 1), ('emulsion', 1), ('mg/ml', 1), ('injectable', 1), ('vials', 1), ('propofol', 1), ('hospira', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014; ACARBOSE, Tablet, 25 mg\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('hydrocortisone', 1), ('distributed', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: PHENobarbital, Tablet, 64.8 mg may have potentially been mislabeled as the following drug: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD73518_4, EXP: 5/31/2014. \n",
"top 10 keywords: [('phenobarbital', 1), ('mg', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('rx', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.\n",
"top 10 keywords: [('fullerton', 1), ('ca', 1), ('upc', 1), ('joint', 1), ('natural', 1), ('capsules', 1), ('pyrola', 1), ('60-count', 1), ('formula', 1), ('c', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: ISONIAZID, Tablet, 300 mg may have potentially been mislabeled as one of the following drugs: hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003690, EXP: 6/26/2014; CETIRIZINE HCL, Tablet, 5 mg, NDC 00378363501, Pedigree: AD32757_13, EXP: 5/13/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD32757_47, EXP: 5/13/2014; DULoxetine HCl DR,\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('isoniazid', 1), ('distributed', 1), ('service', 1), ('llc', 1), ('aidapak', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001, Pedigree: AD25264_7, EXP: 5/3/2014.\n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('torsemide', 1), ('tablet', 1), ('aidapak', 1), ('distributed', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.\n",
"top 10 keywords: [('usp', 3), ('mg', 2), ('bupivacaine', 2), ('lake', 2), ('rx', 2), ('ndc', 2), ('hospira', 2), ('injection', 2), ('hcl', 2), ('forest', 2)]\n",
"---\n",
"reason_for_recall : CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.\n",
"top 10 keywords: [('ndc', 28), ('bottles', 19), ('inc.', 18), ('pharmaceuticals', 15), ('morgantown', 15), ('wv', 15), ('mylan', 14), ('rx', 14), ('amlodipine', 12), ('besylate', 12)]\n",
"---\n",
"reason_for_recall : Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. \n",
"top 10 keywords: [('actelion', 1), ('sterile', 1), ('ampules', 1), ('use', 1), ('south', 1), ('iloprost', 1), ('inc', 1), ('ndc', 1), ('ventavis', 1), ('francisco', 1)]\n",
"---\n",
"reason_for_recall : Chemical contamination: emission of strong odor after package was opened..\n",
"top 10 keywords: [('bottles', 6), ('ndc', 6), ('tablets', 3), ('rx', 3), ('sodium', 3), ('tn', 3), ('bristol', 3), ('pharmaceuticals', 3), ('mcg', 3), ('b', 3)]\n",
"---\n",
"reason_for_recall : Stability Data Does Not Support Expiry\n",
"top 10 keywords: [('sodium', 5), ('ml', 3), ('usp', 3), ('rx', 2), ('units/ml', 2), ('heparin', 2), ('little', 2), ('drug', 2), ('ar', 2), ('upc', 2)]\n",
"---\n",
"reason_for_recall : Lack of assurance of sterility\n",
"top 10 keywords: [('injection', 26), ('bedford', 26), ('pharmacy', 23), ('route', 13), ('nh', 13), ('l.l.c.', 10), ('ny', 10), ('fallon', 10), ('mg/ml', 10), ('latham', 10)]\n",
"---\n",
"reason_for_recall : Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.\n",
"top 10 keywords: [('litres', 2), ('rx', 1), ('ok', 1), ('supplied', 1), ('oxygen', 1), ('care', 1), ('respiratory', 1), ('b', 1), ('cylinders', 1), ('norman', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014. \n",
"top 10 keywords: [('mg', 1), ('distributed', 1), ('ndc', 1), ('lozenge', 1), ('aidapak', 1), ('rx', 1), ('phenol', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide\n",
"top 10 keywords: [('il', 1), ('inj', 1), ('concentrate', 1), ('rx', 1), ('use', 1), ('meq/ml', 1), ('single-dose', 1), ('meq', 1), ('iv', 1), ('fliptop', 1)]\n",
"---\n",
"reason_for_recall : Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.\n",
"top 10 keywords: [('mg', 1), ('tablets', 1), ('acetaminophen', 1), ('oxycodone', 1), ('rx', 1), ('al', 1), ('qualitest', 1), ('cii', 1), ('ndc', 1), ('pharmaceuticals', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Incorrect Package Insert; product packaged with outdated version of the insert\n",
"top 10 keywords: [('tablets', 1), ('rx', 1), ('count', 1), ('mavik¿', 1), ('trandolapril', 1), ('north', 1), ('pharmaceutical', 1), ('nj', 1), ('il', 1), ('usa', 1)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014. \n",
"top 10 keywords: [('mg', 1), ('rx', 1), ('ndc', 1), ('tablet', 1), ('aidapak', 1), ('hydrocortisone', 1), ('distributed', 1), ('service', 1), ('llc', 1)]\n",
"---\n",
"reason_for_recall : Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.\n",
"top 10 keywords: [('usa', 2), ('wockhardt', 2), ('tablets', 1), ('rx', 1), ('30-count', 1), ('llc.', 1), ('waterview', 1), ('succinate', 1), ('distributed', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets\n",
"top 10 keywords: [('elizabeth', 2), ('orally', 1), ('tablets', 1), ('count', 1), ('rx', 1), ('llc.', 1), ('nj', 1), ('bottles', 1), ('mg', 1), ('ndc', 1)]\n",
"---\n",
"reason_for_recall : CGMP Deviation; cotton coil is missing in some packaged bottles\n",
"top 10 keywords: [('tablets', 1), ('mg', 1), ('pharmaceuticals', 1), ('sellersville', 1), ('rx', 1), ('ndc', 1), ('disulfiram', 1), ('tablet', 1), ('pa', 1), ('teva', 1)]\n",
"---\n",
"reason_for_recall : Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.\n",
"top 10 keywords: [('tablets', 2), ('pharmaceuticals', 1), ('ltd.', 1), ('sun', 1), ('elijah', 1), ('distributed', 1), ('ndc', 1), ('india', 1), ('mccoy', 1), ('dadra', 1)]\n",
"---\n",
"reason_for_recall : Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.\n",
"top 10 keywords: [('ml', 2), ('per', 2), ('drug', 1), ('prakanong', 1), ('ltd.', 1), ('acid', 1), ('co.', 1), ('box', 1), ('sukhumvlt', 1), ('thailand', 1)]\n",
"---\n",
"reason_for_recall : Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss\n",
"top 10 keywords: [('nyc', 1), ('china', 1), ('b-lipo', 1), ('km', 1), ('kunming', 1), ('inc.599', 1), ('bethel', 1), ('west', 1), ('190th', 1), ('street', 1)]\n",
"---\n",
"reason_for_recall : cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.\n",
"top 10 keywords: [('jubilant', 2), ('tablets', 1), ('pharmaceuatical', 1), ('count', 1), ('life', 1), ('salisbury', 1), ('bottles', 1), ('inc', 1), ('ndc', 1), ('cadista', 1)]\n",
"---\n",
"reason_for_recall : Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.\n",
"top 10 keywords: [('warner', 5), ('llc', 5), ('tablets', 3), ('rx', 3), ('count', 3), ('pr', 3), ('ndc', 3), ('bottle', 3), ('chilcott', 3), ('company', 3)]\n",
"---\n",
"reason_for_recall : Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.\n",
"top 10 keywords: [('tablets', 4), ('bristol-myers', 4), ('company', 4), ('squibb', 4), ('princeton', 4), ('nj', 4), ('usa', 4), ('rx', 2), ('per', 2), ('physician', 2)]\n",
"---\n",
"reason_for_recall : Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as the following drug: BUMETANIDE, Tablet, 1 mg, NDC 00093423301, Pedigree: W003224, EXP: 6/17/2014. \n",
"top 10 keywords: [('phosphate', 1), ('er', 1), ('ndc', 1), ('aidapak', 1), ('mg', 1), ('distributed', 1), ('llc', 1), ('service', 1), ('capsule', 1), ('carvedilol', 1)]\n",
"---\n",
"