Categories
Drug Recalls

FDA Drug Recalls Analysis

Which Pharmaceutical Companies Were Involved in the Most Recalled Drugs in the last 3 years?

The table below shows the company name and the total number of recalled products they had from October 2017 to November 2019.

Company NameTotal Recalls
Hospira, Inc.7
Torrent Pharmaceuticals, Limited7
AuroMedics Pharma LLC5
Altaire Pharmaceuticals, Inc.4
Legacy Pharmaceutical Packaging4
PharMEDium Services, LLC4
Apotex Corp.3
Baxter International Inc.3
Hospira Inc.3
ICU Medical, Inc.3
Advanced Pharma, Inc. d/b/a Avella of Houston2
Alvogen2
American Health Packaging2
Apace Packaging LLC2
Aurobindo Pharma USA, Inc.2
AuroMedics Pharma2
Bristol-Myers Squibb2
C.O. Truxton, Inc.2
Camber Pharmaceuticals, Inc.2
Dr. Reddy’s Laboratories Ltd.2
Fagron Sterile Services2
Fresenius Kabi USA2
International Laboratories, LLC2
King Bio2
Kiriko, LLC2
MarcasUSA, LLC2
McDaniel Life-Line LLC2
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC2
Sagent Pharmaceuticals2
Synergy Rx Pharmacy2
Teva Pharmaceuticals USA, Inc2
Abbott1
Accord Healthcare Inc.1
Allergan1
Altaire Pharmaceuticals Inc.1
Altaire Pharmaceuticals, Inc1
Altaire Pharmaceuticals, Inc.,1
AMA Wholesale Inc.1
AmEx Pharmacy1
Amneal Pharmaceuticals LLC1
Amneal Pharmaceuticals, LLC1
Andropharm1
Apotex Corporation1
Asclemed USA Inc dba Envoachem Pharmeceuticals1
Astrazeneca1
Aurobindo Pharma Limited1
AurobindoPharma USA, Inc.1
Avella Specialty Pharmacy1
Baxter International Inc1
Bayer1
BD1
Beaumont Bio Med, Inc.1
Bella Pharmaceuticals, Inc.1
BioLyte Laboratories1
Blissful Remedies1
Camber Pharmaceuticals, Inc1
Cardinal Health1
Caverflo.com1
Centurion Labs1
Darmerica LLC1
Eight and Company LLC, dba Sprayology1
Endo Pharmaceuticals1
Endo Pharmaceuticals Inc.1
Envy Me1
Exela Pharma Sciences, LLC1
EZ Weight Loss TX1
Fagron Inc.1
Fat Burners Zone1
Fitoterapia USA Inc.1
Fresenius Kabi USA, LLC1
Gaia Ethnobotanical, LLC1
Genentech1
GL Holdings1
Golean Detox USA1
Greenstone LLC, a wholly owned subsidiary of Pfizer Inc.1
GSMS, Inc.1
Happy Together, Inc.1
Hardcore Formulations1
HelloLife, Inc.1
Herbal Doctor Remedies1
Heritage Pharmaceuticals Inc.1
Hospira Inc, A Pfizer Company1
Infusion Options Inc.1
Innoveix Pharmaceuticals, Inc.1
Isomeric Pharmacy Solutions1
Janssen Pharmaceuticals, Inc.1
Jubilant Cadista Pharmaceuticals Inc.1
Kadesh Inc.1
Kareway Products Inc.1
King Bio Inc.1
Kingston Pharma, LLC1
KRS Global Biotechnology1
Lake Michigan Distilling Company, LLC dba Ethanol Extraction1
Lannett Company, Inc.1
Liveyon, LLC1
Lucky Mart Inc.1
Lupin Pharmaceuticals Inc.1
Lupin Pharmaceuticals, Inc.1
Macleods Pharmaceutical Limited1
Macleods Pharmaceuticals Limited1
Magno-Humphries Laboratories, Inc.1
Major Pharmaceuticals1
Man of Steel1
Marmex Corp1
MBI Distributing, Inc.1
Med Man Distribution1
Mid Valley Pharmaceutical1
MusclMasster LLC1
Mylan Institutional LLC1
Mylan Pharmaceuticals1
Mylan Pharmaceuticals Inc.1
Nature’s Rx1
Novartis1
NOVIS PR LLC1
Novitium Pharma1
Nuway Distributors1
Organic Herbal Supply, Inc.1
Oscor Inc.1
Pacifico National, Inc. dba AmEx Pharmacy1
Par Pharmaceutical, Inc.1
Perrigo Company plc1
Pfizer Inc1
Pfizer, Inc.1
Pharm D Solutions LLC1
Pharm D Solutions, LLC1
PharMEDium Services1
PharMEDium Services LLC1
Phillips Company1
Plastikon Healthcare1
Precision Dose Inc.1
Premier Pharmacy Labs1
Premier Pharmacy Labs Inc1
Primus Pharmaceuticals, Inc.1
Product Quest Manufacturing (Product Quest)1
Product Quest Manufacturing LLC1
Promise Pharmacy1
Ranier’s RX Laboratory1
Results RNA LLC1
Ridge Properties DBA Pain Relief Naturally1
Ridge Properties LLC DBA Pain Relief Naturally1
Rugby Laboratories1
RXQ Compounding LLC1
Sandoz Inc1
Sandoz Inc.1
Sanofi1
SCA Pharmaceuticals LLC1
SCA Pharmaceuticals LLC (SCA Pharma)1
ScieGen Pharmaceuticals, Inc1
SD Imports1
Shadow Holdings1
Shoreside Enterprises1
Simple Diagnostics1
Standard Homeopathic Company1
Stokes Healthcare, Inc.1
Sun Pharmaceutical Industries Ltd1
Sun Pharmaceutical Industries, Inc1
Takeda Pharmaceutical Company Limited1
Terrific Care, LLC. / Medex Supply Dist, Inc.1
Teva Pharmaceuticals1
Teva Pharmaceuticals USA1
Teva Pharmaceuticals USA, Inc.1
Torrent Pharmaceuticals1
Tris Pharma1
Tris Pharma, Inc.1
Ultra Shop Supplement1
USA LESS1
Viatrexx Bio Incorporated1
Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding1
Vivimed1
Westminster Pharmaceuticals, LLC1
World Organix, LLC1

What were the main reasons drugs were recalled by the FDA?

Recall Reason DescriptionTotal
Due to lack of sterility assurance11
Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)8
Lack of sterility assurance8
Due to detection of NDEA (N-Nitrosodiethylamine) Impurity7
Due to the presence of particulate matter7
Lack of sterility7
Mislabeling6
Microbial Contamination4
Due to Possible Microbial Contamination3
Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity3
Potential for nonsterility3
Potential lack of sterility assurance3
Presence of particulate matter3
Due to Mislabeling2
Due to Potential Contamination of high levels of yeast, mold, and bacteria2
Foreign Material2
Impurity2
May contain N-Nitrosodimethylamine (NDMA)2
Potential contamination with Burkholderia cepacia2
Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA2
Unapproved new drug2
Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine2
Undeclared Sildenafil and Tadalafil2
Undeclared Tadalafil2
Adverse event reports indicative of infusion reactions1
Adverse reactions1
All products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP)1
Another medicine present1
Bacteria1
Burkholderia Cepacia1
Connector cap housing may slide and potentially expose the connection wire1
Contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)1
Contain derivatives of anabolic steroids1
Contains glass particles1
Contains N-Nitrosodimethylamine (NDMA)1
Contains Tadalafil1
Contaminated with Pseudomonas aeruginosa1
Cyclobenzaprine HCL may contain Amantadine HCL Capsules1
Detection of an impurity � N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)1
Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity1
Dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL)1
Due to a High Level of Preservative1
Due to a Potential Lack of Sterility Assurance1
Due to above levels of N-Nitrosodimethylamine (NDMA)1
Due to adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis1
Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)1
Due to concerns of QA controls in the manufacturing facility1
Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)1
Due to detection of N-Nitrosodiethylamine (NDEA)1
Due to Dissolution Test Failure1
Due to High Microbial Loads Contamination1
Due to High Out of Specification Impurity Results1
Due to Incorrect Active Ingredient1
Due to Incorrect Veridate Dispenser Instructions1
Due to Labeling Error on Declared Strength1
Due to Labeling Mix-up1
Due to lack of assurance of sterility1
Due to Latex Hazard1
Due to microbial growth1
Due to Microbiological Contamination1
Due to Misprinted Dosing Droppers1
Due to Non-Sterile Production Conditions1
Due to Out of Sequence Capsules1
Due to out of specification (OOS) dissolution results at the 3-month stability time point1
Due to Possible Sub Potent and Super Potent Tablets1
Due to Potential Higher Concentrations of Ibuprofen1
Due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA1
Due to Potential Of Cracked Glass At The Rim Surface Of The Vials1
Due to Potential Peanut Contamination1
Due to Presence of Glass Particulates1
Due to Presence of Particulates Identified as Glass and Silicone Material1
Due to Presence of Precipitate1
Due to presence of Sibutramine1
Due to presence of Sildenafil1
Due to Presence of Undeclared Sibutramine1
Due to Presence of Undeclared Sildenafil1
Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex1
Due to Product Mislabeling1
Due to Product Mix-up1
Due to Risk of Adulteration1
Due to Small Particulate Floating in the Solution1
Due To Sub-Potency1
Due to the Detection of N-Methylnitrosobutyric acid (NMBA)1
Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA)1
Due to the detection of trace amounts of N-nitrosodiethylamine (NDEA)1
Due to the Potential for Burr Particulate1
Due to The Potential for Empty or Cracked Glass Vials1
Due to unapproved active ingredient (sildenafil)1
Found to exhibit a slight discoloration in the admixture1
Higher Concentration of Ibuprofen1
Inaccurate lead test results1
Inaccurately reporting high INR test results1
Incorrect Daily Dosing Information on Label1
Incorrect dosage on label1
Ingredient Level1
Label mix-up1
Label Mix-up Error1
Labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets1
Labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets1
Labeling1
Lack of Adequate Controls1
Lack of Quality Assurance1
Lack of Sterility Process Assurance1
Manufacturing Concerns1
Manufacturing Practices1
may contain the probable carcinogen Nnitrosodimethylamine (NDMA)1
Methanol1
microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.1
Microbial Contamination (Scopulariopsis brevicaulis)1
Microbiological Contamination1
Microbiological Contamination and Superpotency1
Mislabeled1
Mislabeling-The ingredients on the front sticker may not match the actual product in the carton1
Missing Expiry1
NDMA (Nitrosodimethylamine)1
NDMA (Nitrosodimethylamine) impurity1
Possibility of Missing/Incorrect Tablet Arrangement1
Possible contamination1
Possible microbial contamination1
Potential for glass particulate1
Potential for non-sterility1
Potential Foreign Material1
Potential Inaccuracy of Latex Free Label Reference1
Potential Labeling Issue1
Potential microbial contamination which compromises sterility1
Potential of Foreign Material1
Potential presence of foreign substance1
Potential presence of rubber particulate1
potential safety risk to patients, such as low blood flow or clotting.1
Potential to be contaminated with Bacillus cereus/ Bacillus circulans1
Potential to be contaminated with Salmonella1
Potentially contain microbial contamination in the non-sterile Suturagel1
Presence of Ephedra Herb, an FDA banned ingredient1
Presence of Glass Particles in Vial1
Presence of NMBA impurity1
Presence of N-Nitrosodimethylamine (NDMA)1
Product Defect1
Product exposed to subfreezing temperatures1
Product is tainted with sildenafil1
Salmonella1
Small Glass Particles1
Some of the vials have been found to contain particulate matter1
Sterility Concerns and Undeclared Colloidal Silver1
Sterility Failure1
Sub-Potency1
The electronic customer ordering system stated it is sulfite-free, but the product contains sulfite.1
Unapproved drug. Marketed without an approved NDA/ANDA1
Unapproved drugs1
Unapproved Ingredient1
Undeclared Active Ingredients tadalafil, sildenafil and analogues1
Undeclared Active Pharmaceutical Ingredients and Undeclared Milk1
Undeclared Sildenafil1
Visible Particulate Matter1
White particulate matter that has been identified as mold1

The following drugs were recalled by the FDA. This table represents data from October 2017 to November 2019.

DateBrand Name(s)Product DescriptionRecall Reason DescriptionCompany Name
11/22/19AmnealRanitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mLDue to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDAAmneal Pharmaceuticals, LLC
11/19/19PrecisionDoseRanitidine Oral Solution, USP 150 mg/10 mLPotential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDAPrecision Dose Inc.
11/15/19GSMS IncorporatedRanitidine HCl 150mg and 300mg CapsulesPotential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDAGSMS, Inc.
11/13/19Silver BulletMale Enhancement CapsulesDue to unapproved active ingredient (sildenafil)Nature’s Rx
11/8/19AHPRanitidine Liquid Unit Dose CupsNDMA (Nitrosodimethylamine) impurityAmerican Health Packaging
11/8/19Up2Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary SupplementProduct is tainted with sildenafilMed Man Distribution
11/6/19Aurobindo & DG HealthRanitidineNDMA (Nitrosodimethylamine)Aurobindo Pharma USA, Inc.
11/5/19ViatrexxSterile injectable productsLack of sterility assuranceViatrexx Bio Incorporated
11/1/19FagronLETS GEL KIT Convenience PacksPotentially contain microbial contamination in the non-sterile SuturagelFagron Inc.
10/30/19ICU Medical, Inc.Lactated Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USPDue to the presence of particulate matterICU Medical, Inc.
10/26/19Mylan Pharmaceuticals Inc.Alprazolam Tablets, USP C-IV 0.5 mgPotential presence of foreign substanceMylan Pharmaceuticals Inc.
10/25/19Lannett Company, Inc.Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mLDue to above levels of N-Nitrosodimethylamine (NDMA)Lannett Company, Inc.
10/25/19Novitium PharmaRanitidine Hydrochloride Capsules 150 mg and 300 mgMay contain N-Nitrosodimethylamine (NDMA)Novitium Pharma
10/23/19Dr. Reddy’s, Kroger, Walgreens, and othersRanitidine Tablets & CapsulesContains N-Nitrosodimethylamine (NDMA)Dr. Reddy’s Laboratories Ltd.
10/23/19SanofiZantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products)May Contain N-Nitrosodimethylamine (NDMA)Sanofi
10/23/19Perrigo Company plcRanitidine (all pack sizes)Presence of N-Nitrosodimethylamine (NDMA)Perrigo Company plc
10/22/19Green LumberDietary supplements for male sexual enhancementContains TadalafilGL Holdings
10/10/19Innoveix Pharmaceuticals, Inc.Injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2Potential lack of sterility assuranceInnoveix Pharmaceuticals, Inc.
9/25/19Apotex Corp.Ranitidine Tablets 75mg and 150mgContain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)Apotex Corp.
9/23/19Sandoz Inc.Ranitidine Hydrochloride CapsulesDue to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)Sandoz Inc.
9/19/19Torrent PharmaLosartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USPDue to the Detection of N-Methylnitrosobutyric acid (NMBA)Torrent Pharmaceuticals Limited
9/16/19MachoMACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENTUndeclared TadalafilFitoterapia USA Inc.
9/12/19Darmerica LLCQuinacrine Dihydrochloride, bulk API powderLabel mix-upDarmerica LLC
9/12/19KRS Global BiotechnologyHuman Sterile Drug ProductsLack of Sterility AssuranceKRS Global Biotechnology
9/9/19Major PharmaceuticalsMilk of Magnesia Oral Suspension 2400 mg/30 mlMicrobial ContaminationPlastikon Healthcare
9/6/19Hospira Inc.Bacteriostatic Water for InjectionPotential Lack of Sterility AssuranceHospira Inc.
9/5/19NatparaParathyroid Hormone for InjectionPotential presence of rubber particulateTakeda Pharmaceutical Company Limited
8/30/19AmEx PharmacyBevacizumab 1.25mg/0.05mL 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB InjectablePotential for non-sterilityPacifico National, Inc. dba AmEx Pharmacy
8/22/19Dechra Veterinary ProductsVeterinary ophthalmic drug productsDue to concerns of QA controls in the manufacturing facilityAltaire Pharmaceuticals, Inc.
8/15/19RELPAXRELPAX® (eletriptan hydrobromide) 40 mg tabletsMicrobiological ContaminationPfizer Inc
8/8/19TAT Balm, Naturally HL4% Lidocaine topical cream & liquid gel productsMicrobiological Contamination and SuperpotencyRidge Properties LLC DBA Pain Relief Naturally
7/24/19Herbal Doctor RemediesDrug productsAll products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP)Herbal Doctor Remedies
7/23/19CadistaDrospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mgDue to out of specification (OOS) dissolution results at the 3-month stability time pointJubilant Cadista Pharmaceuticals Inc.
7/16/19OCuSOFTPrescription (RX) and Over-the-Counter (OTC) Ophthalmic productsDue to lack of sterility assuranceAltaire Pharmaceuticals, Inc.,
7/15/19Altaire Pharmaceuticals, Inc.OTC and Rx Ophthalmic ProductsDue to lack of sterility assuranceAltaire Pharmaceuticals Inc.
7/15/19AlvogenFentanyl Transdermal SystemDue to Product MislabelingAlvogen
7/15/19LegacyLosartan Potassium USPDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Legacy Pharmaceutical Packaging
7/15/19Equate and Support HarmonyOver-the-Counter (OTC) drug productsPotential for nonsterilityAltaire Pharmaceuticals, Inc.
7/10/19CVS HealthMultiple Ophthalmic ProductsDue to lack of assurance of sterilityAltaire Pharmaceuticals, Inc
7/5/19Equate and Support HarmonyOver-the-Counter (OTC) drug productsPotential for nonsterilityAltaire Pharmaceuticals, Inc.
7/3/19PerrigoOphthalmic ointmentsPotential for nonsterilityAltaire Pharmaceuticals, Inc.
7/2/19Fresenius Kabi, NovaplusFluorouracil InjectionPotential for glass particulateFresenius Kabi USA, LLC
6/28/19PharMEDium0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD SyringeThe electronic customer ordering system stated it is sulfite-free, but the product contains sulfite.PharMEDium Services, LLC
6/26/19MacleodsLosartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tabletsPresence of NMBA impurityMacleods Pharmaceutical Limited
6/20/19Infusion Options Inc.All sterile products within expiryLack of Sterility AssuranceInfusion Options Inc.
6/18/19Premier Pharmacy LabsAll Products Intended to be SterileLack of Sterility AssurancePremier Pharmacy Labs Inc
6/18/19RXQ Compounding LLCAll sterile human and animal products within expiry.Lack of Sterility Process AssuranceRXQ Compounding LLC
6/11/19GSMS Inc.Losartan potassium tabletsDetection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)Teva Pharmaceuticals USA, Inc.
5/29/19Pecgen DMX,PECGEN DMX, 16 oz, liquid cough syrupIncorrect dosage on labelNOVIS PR LLC
5/28/19HeritageAmikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL)Sterility FailureHeritage Pharmaceuticals Inc.
5/23/19Pharm D SolutionsSterile Compounded Drug ProductsLack of sterility assurancePharm D Solutions, LLC
5/12/19PromactaPromacta 12.5 mg oral suspensionDue to Potential Peanut ContaminationNovartis
5/3/19WP Westminster, moreIrbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage formsDue to detection of NDEA (N-Nitrosodiethylamine) ImpurityScieGen Pharmaceuticals, Inc
5/3/19Par PharmaceuticalMycophenolate Mofetil for injectionForeign MaterialPar Pharmaceutical, Inc.
5/3/19HeritageLosartan Potassium Tablets USPLack of sterilityVivimed
5/2/19Endo PharmaceuticalsRobaxin® (methocarbamol tablets, USP) 750mg TabletsIncorrect Daily Dosing Information on LabelEndo Pharmaceuticals
4/30/19Sagent PharmaceuticalsKetorolac Tromethamine InjectionLack of SterilitySagent Pharmaceuticals
4/29/19AmEx PharmacyBevacizumab 1.25mg/0.05mL 31G InjectableProduct DefectAmEx Pharmacy
4/26/19GSMS IncorporatedLosartan Potassium 25 mg and 100 mg Tablets USPDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Teva Pharmaceuticals USA, Inc
4/18/19Torrent Pharmaceuticals LimitedLosartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USPDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Torrent Pharmaceuticals Limited
4/12/19Platinum 40000Aphrodisiac capsulesUnapproved IngredientSD Imports
3/28/19LegacyLosartan Potassium USPDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Legacy Pharmaceutical Packaging
3/25/19LeopardDietary SupplementUndeclared SildenafilUSA LESS
3/20/19DG™/health NATURALSbaby Cough Syrup + MucusPotential to be contaminated with Bacillus cereus/ Bacillus circulansKingston Pharma, LLC
3/19/19LegacyLosartan Potassium USPDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Legacy Pharmaceutical Packaging
3/18/19MylanLevoleucovorin Injection, 250 mg/25 mLPresence of particulate matterMylan Institutional LLC
3/15/19LegacyLosartan Potassium USPDue to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA)Legacy Pharmaceutical Packaging
3/15/19HospiraSodium bicarbonate injection USPPresence of Particulate MatterHospira, Inc.
3/13/19Stokes HealthcarePilocarpine opthalmic solutionDue to a High Level of PreservativeStokes Healthcare, Inc.
3/7/19Aurobindo Pharma USA, Inc.Valsartan Tablets USPDue to detection of N-Nitrosodiethylamine (NDEA)American Health Packaging
3/6/19Life-Line tmAdditive for human drinking waterContaminated with Pseudomonas aeruginosaMcDaniel Life-Line LLC
3/1/19Torrent PharmaLosartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USPDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Torrent Pharmaceuticals Limited
3/1/19Aurobindo, AcetrisValsartan and Amlodipine and Valsartan tabletsDue to the detection of NDEA (N-Nitrosodiethylamine) ImpurityAurobindoPharma USA, Inc.
3/1/19Apotex Corp.Drospirenone and Ethinyl Estradiol Tablets, USPPossibility of Missing/Incorrect Tablet ArrangementApotex Corp.
2/28/19Camber Pharmaceuticals, Inc.Losartan Tablets USP 25 mg, 50 mg, and 100 mgDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Camber Pharmaceuticals, Inc.
2/26/19ChemoLock and ChemoClaveVial SpikesDue to the Potential for Burr ParticulateICU Medical, Inc.
2/25/19Golean DetoxDietary Supplement for Weight LossMislabelingGolean Detox USA
2/22/19MacleodsLosartan Potassium/Hydrochlorothiazide Combination TabletsDue to detection of NDEA (N-Nitrosodiethylamine) ImpurityMacleods Pharmaceuticals Limited
2/8/19McDaniel Life-LineIndian Herb (topical)Unapproved drug. Marketed without an approved NDA/ANDAMcDaniel Life-Line LLC
2/4/19Dr. Reddy’s Laboratories Ltd.Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection)MislabelingDr. Reddy’s Laboratories Ltd.
1/29/19CVS, EquateOral ibuprofenHigher Concentration of IbuprofenTris Pharma, Inc.
1/22/19Torrent Pharmaceuticals LimitedLosartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USPLack of SterilityTorrent Pharmaceuticals Limited
1/18/19Prinston Pharmaceutical Inc. dba Solco Healthcare LLCIrbesartan and Irbesartan HCTZ TabletsDue to the detection of NDEA (N-Nitrosodiethylamine) ImpurityPrinston Pharmaceutical Inc. dba Solco Healthcare LLC
1/8/19Sun PharmaVecuronium Bromide for InjectionPotential Foreign MaterialSun Pharmaceutical Industries, Inc
1/8/19RhinoRhino 5K capsulesUndeclared Sildenafil and TadalafilHappy Together, Inc.
1/5/19Lupin Pharmaceuticals, Inc.Ceftriaxone for Injection, USPForeign MaterialLupin Pharmaceuticals, Inc.
1/3/19Torrent Pharmaceuticals LimitedLosartan potassium tablets, USPDue to the detection of trace amounts of N-nitrosodiethylamine (NDEA)Torrent Pharmaceuticals Limited
1/2/19LubrisineEye DropsSterility Concerns and Undeclared Colloidal SilverResults RNA LLC
12/31/18AurobindoAmlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USPDue to detection of NDEA (N-Nitrosodiethylamine) ImpurityAurobindo Pharma USA, Inc.
12/20/18Torrent Pharmaceuticals LimitedLosartan potassium tablets, USPDue to detection of NDEA (N-Nitrosodiethylamine) ImpurityTorrent Pharmaceuticals Limited
12/19/18Terrific Care LLC dba MedEx SupplyRoche CoaguChek test stripsInaccurately reporting high INR test resultsTerrific Care, LLC. / Medex Supply Dist, Inc.
12/17/18Envoachem PharmaceuticalsDyural-40 and Dyural-80Due to Latex HazardAsclemed USA Inc dba Envoachem Pharmeceuticals
12/6/18Family Wellness, CVS, EquateInfants’ IbuprofenDue to Potential Higher Concentrations of IbuprofenTris Pharma
12/4/18MylanValsartan-containing productsDue to the detection of NDEA (N-Nitrosodiethylamine) ImpurityMylan Pharmaceuticals
11/27/18Teva PharmaceuticalsAmlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination TabletsDue to detection of NDEA (N-Nitrosodiethylamine) ImpurityTeva Pharmaceuticals
11/21/18Fresenius KabiSodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vialDue to Product Labeling Incorrectly Stating Stoppers Do Not Contain LatexFresenius Kabi USA
11/12/18OscorTemporary Bipolar Pacing Lead, Model TBConnector cap housing may slide and potentially expose the connection wireOscor Inc.
11/9/18LosartanPotassium HydrochlorothiazideDue to detection of NDEA (N-Nitrosodiethylamine) ImpuritySandoz Inc
11/7/18PuritonPuriton Eye Relief Drops, 0.5 oz. (15ml) bottleDue to Non-Sterile Production ConditionsKadesh Inc.
11/2/18ORTHO-NOVUMORTHO-NOVUM 1/35 and 7/7/7Due to Incorrect Veridate Dispenser InstructionsJanssen Pharmaceuticals, Inc.
10/29/18Aurobindo Pharma LimitedIrbesartan DrugDue to detection of NDEA (N-Nitrosodiethylamine) ImpurityAurobindo Pharma Limited
10/22/18Promise PharmacyPrednisolone and Gatifloxacin Ophthalmic SolutionDue to Small Particulate Floating in the SolutionPromise Pharmacy
10/18/18Zero XtremeDietary Supplement for Weight LossDue to Presence of Undeclared SibutramineFat Burners Zone
10/10/18ReGen SeriesAll ReGen Series productsAdverse reactionsLiveyon, LLC
10/10/18SprayologyHomeopathic Aqueous-Based MedicinesPossible microbial contaminationEight and Company LLC, dba Sprayology
9/13/18NeoReliefMuscleDue to Possible Microbial ContaminationBioLyte Laboratories
9/10/18Pharm D SolutionsCompounded drugsLack of SterilityPharm D Solutions LLC
9/7/18SCA PharmaceuticalsFurosemide 100 mg in 0.9% Sodium Chloride 100 mg bagDue to Presence of PrecipitateSCA Pharmaceuticals LLC (“SCA Pharma”)
9/7/18Camber PharmaceuticalsMontelukast Sodium Tablets, USP 10mgMislabelingCamber Pharmaceuticals, Inc
9/6/18Beaumont Bio Med HomeopathicHomeopathic oral spraysDue to Possible Microbial ContaminationBeaumont Bio Med, Inc.
8/29/18CVS, Rhinall, Humist, moreNasal Products and Baby Oral GelsMicrobial ContaminationProduct Quest Manufacturing LLC
8/29/18Neuroveen, Respitrol, Thyroveev, CompulsinHomeopathic MedicinesDue to Possible Microbial ContaminationHelloLife, Inc.
8/28/18Dr. King’sHomeopathic products for human and animal useMicrobial ContaminationKing Bio
8/28/18Children’s AdvilIbuprofen Oral SuspensionDosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL)Pfizer, Inc.
8/27/18AccordHydrochlorothiazide Tablets USP 12.5 mgDue to Labeling Mix-upAccord Healthcare Inc.
8/24/18Torrent Pharmaceuticals LimitedValsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tabletsImpurityTorrent Pharmaceuticals Limited
8/24/18KB, DK, moreHomeopathic productsMicrobial contaminationKing Bio
8/17/18TorrentValsartan/Amlodipine/HCTZ TabletsDue to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA)Torrent Pharmaceuticals
8/16/18Blissful RemediesProducts Containing KratomDue to High Microbial Loads ContaminationWorld Organix, LLC
8/14/18Kratom Powder CapsuleKratom Powder CapsulePotential to be contaminated with SalmonellaBlissful Remedies
8/10/18Westminster Pharmaceuticals, LLCLevothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mgDue to Risk of AdulterationWestminster Pharmaceuticals, LLC
8/9/18Camber Pharmaceuticals, Inc.Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mgDetection of Trace Amounts of N-Nitrosodimethylamine (NDMA) ImpurityCamber Pharmaceuticals, Inc.
8/8/18ActavisValsartan and Valsartan Hydrochlorothiazide TabletsImpurityTeva Pharmaceuticals USA
8/8/18CVS Health12 Hour Sinus Relief Nasal MistDue to Microbiological ContaminationProduct Quest Manufacturing (“Product Quest”)
7/31/18AuromedicsPiperacillin and Tazobactam for injection, USP 3.375 gDue to Presence of Particulates Identified as Glass and Silicone MaterialAuroMedics Pharma
7/28/18Ranier’s RX LaboratoryCompounded drug productsDue to Lack of Sterility AssuranceRanier’s RX Laboratory
7/20/18Dr. King’s, Dr. King’s AquafloraHomeopathic liquids: Candida liquid, lymph detox liquid, baby teething liquidmicrobial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.King Bio Inc.
7/18/18Prinston Pharmaceutical Inc. dba Solco Healthcare LLCValsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mgDue to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
7/16/18Major PharmaceuticalsValsartan tablets, 80mg USP and 160 mg USPmay contain the probable carcinogen Nnitrosodimethylamine (NDMA)Major Pharmaceuticals
7/2/18Fagron Sterile ServicesNeostigmine Methylsulfate 5 mL SyringesMislabelingFagron Sterile Services
6/27/18HospiraDaptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose VialAdverse event reports indicative of infusion reactionsHospira Inc.
6/21/18Gaia EthnobotanicalKratom ProductsSalmonellaGaia Ethnobotanical, LLC
6/4/18HospiraNaloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use cartridge Syringe SystemPotential of Foreign MaterialHospira Inc.
5/31/18ApotexFluticasone Propionate Nasal SpraySmall Glass ParticlesApotex Corp.
5/31/18HeartMate 3Left Ventricular Assist Devicepotential safety risk to patients, such as low blood flow or clotting.Abbott
5/29/18TaytullaBirth control capsulesDue to Out of Sequence CapsulesAllergan
5/25/18X-Jow, Acne ShavePain Gel, Moisturizer, Shave CreamBacteriaShadow Holdings
5/23/18Ethanol Extraction/Lake Michigan Distilling Company, LLC95% Ethyl Alcohol productMethanolLake Michigan Distilling Company, LLC dba Ethanol Extraction
5/18/18MBI Distributing, Inc.Various Homeopathic ProductsLack of Adequate ControlsMBI Distributing, Inc.
5/17/187K and Poseidon7K and Poseidon 4500 Dietary SupplementsUndeclared Sildenafil and TadalafilShoreside Enterprises
5/14/18AuroMedics Pharma LLCPiperacillin and Tazobactam for injection, USP 3.375 g/vialDue to Presence of Glass ParticulatesAuroMedics Pharma LLC
5/14/18AuroMedics Pharma LLCAmpicillin and Sulbactam for Injection USP, 3 grams/ Single-Dose vialVisible Particulate MatterAuroMedics Pharma LLC
5/14/18Apotex CorporationPiperacillin and Tazobactam for InjectionIngredient LevelApotex Corporation
4/13/18AMA Wholesale Inc.Rhino 69 Extreme 50000 capsulesUndeclared tadalafilAMA Wholesale Inc.
4/11/18Premier Pharmacy LabsSterile Injectable Drug ProductsDue to a Potential Lack of Sterility AssurancePremier Pharmacy Labs
4/3/18PASTA DE LASSAR ANDROMACOPasta De Lassar Andromaco Skin ProtectantDue to Potential Contamination of high levels of yeast, mold, and bacteriaMarcasUSA, LLC
4/3/18PASTA DE LASSAR ANDROMACOPasta De Lassar Andromaco Skin ProtectantDue to Potential Contamination of high levels of yeast, mold, and bacteriaMarcasUSA, LLC
3/22/18BDVacutainer tubesInaccurate lead test resultsBD
3/16/18BayerAlka-Seltzer PlusMislabeling-The ingredients on the front sticker may not match the actual product in the cartonBayer
3/6/18SagentMethylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1gDue to High Out of Specification Impurity ResultsSagent Pharmaceuticals
3/5/18Hospira, Inc.Hydromorphone HCL Injection, USPDue to The Potential for Empty or Cracked Glass VialsHospira, Inc.
2/23/18Hospira, NovaplusLabetalol Hydrochloride Injection, USPDue to Potential Of Cracked Glass At The Rim Surface Of The VialsHospira, Inc.
2/15/18AVpakAcyclovir Tablet, USP, 400mg, 50ct Unit DoseDue to Product Mix-upApace Packaging LLC
2/9/18Bella PharmaAll lots of unexpired sterile drug productsLack of SterilityBella Pharmaceuticals, Inc.
2/9/18LaBri’s Body HealthDietary SupplementMislabelingEnvy Me
2/8/18Doctor ManzanillaAllergy, cough medicineBurkholderia CepaciaMid Valley Pharmaceutical
2/8/18Man of SteelMan of Steel 1 and Man of Steel 2Due to Presence of Undeclared SildenafilMan of Steel
2/8/18EdexAlprostadil for injectionPotential Lack of Sterility AssuranceEndo Pharmaceuticals Inc.
2/8/18Astrazenecaprofessional (physician) sample BRILINTA (ticagrelor) 90mg tabletsAnother medicine presentAstrazeneca
2/8/18Uproar, Cummor, Zrect, Monkey Business and othersDietary SupplementUndeclared Active Ingredients tadalafil, sildenafil and analoguesOrganic Herbal Supply, Inc.
2/8/18Hospira, Inc.Vancomycin Hydrochloride for injectionDue to the Presence of Particulate MatterHospira, Inc.
2/8/18GenentechActivase® (alteplase) 100mg vialsDue to Lack of Sterility AssuranceGenentech
2/8/18Amneal Pharmaceuticals LLCLorazepam Oral Concentrate, USP 2mg/mLDue to Misprinted Dosing DroppersAmneal Pharmaceuticals LLC
2/8/18Baxterintravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USPLabeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tabletsBaxter International Inc.
2/8/18RugbyDiocto Liquid and Diocto SyrupPotential contamination with Burkholderia cepaciaRugby® Laboratories
2/8/18Hyland’sBaby teething tablets and Nightime teething tabletsMislabelingStandard Homeopathic Company
2/8/18Bristol-Myers SquibbEliquis (apixaban) 5 mg TabletsPotential Labeling IssueBristol-Myers Squibb
2/8/18PiyanpingAnti-Itch LotionDue to Incorrect Active IngredientLucky Mart Inc.
2/8/18Tetracycline-ABC, Tetrastem, Diabecline and moretopical productsManufacturing PracticesPhillips Company
2/8/18X-GenIbuprofen Lysine Injection, 20 mg/2 mLSome of the vials have been found to contain particulate matterExela Pharma Sciences, LLC
2/8/18The Green HerbAL-ER-G dietary supplementPresence of Ephedra Herb, an FDA banned ingredientMusclMasster LLC
2/8/18AlvogenClindamycin Injection USPDue to Lack of Sterility AssuranceAlvogen
2/8/18Hospira, Inc.25% Dextrose Injection, USP (Infant)Due to the Presence of Particulate MatterHospira, Inc.
2/8/18Synergy Rx PharmacyNon-sterile drug productsLack of Quality AssuranceSynergy Rx Pharmacy
2/8/18ApexxxDietary SupplementDue to presence of SildenafilNuway Distributors
2/8/18ICU Medical, Inc.0.9% Sodium Chloride Injection, USP 1000 mLDue to the Presence of Particulate MatterICU Medical, Inc.
2/8/18Fagron Sterile ServicesSuccinylcholine Chloride 20mg/mLLack of Sterility AssuranceFagron Sterile Services
2/8/18AndropharmSten Z and M1 Alphas capsulesContain derivatives of anabolic steroidsAndropharm
2/8/18C.O. Truxton, Inc.Phenobarbital Tablets, USP, 15 mgDue to Labeling Error on Declared StrengthC.O. Truxton, Inc.
2/8/18LaBri’s Body HealthDietary SupplementDue to presence of SibutramineEZ Weight Loss TX
2/8/18Super Panther 7KDietary SupplementUnapproved new drugUltra Shop Supplement
2/7/18PharMEDiumPotassium Phosphate and Succinylcholine Chloride Intravia BagsDue to Lack of Sterility AssurancePharMEDium Services
2/7/18Synergy Rx PharmacyHuman Chorionic Gonadotropin (HCG)for injectionDue to Lack of Sterility AssuranceSynergy Rx Pharmacy
2/7/18Bristol-Myers SquibbEliquis (apixaban) 5 mg TabletsLabelingBristol-Myers Squibb
2/7/18Ultra-Sten, D-ZineMarketed as a dietary supplementUnapproved drugsHardcore Formulations
2/7/18Apace Packaging LLCCyclobenzaprine HCl Tablet and Amantadine HCl CapsuleCyclobenzaprine HCL may contain Amantadine HCL CapsulesApace Packaging LLC
2/7/18Isomeric Pharmacy SolutionsMultiple compounded sterile productsDue to Lack of Sterility AssuranceIsomeric Pharmacy Solutions
2/6/18Hospira8.4% Sodium Bicarbonate Injection, USP, NeutTM (Sodium Bicarbonate 4% additive solution), QUELICINTM (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USPDue to microbial growthHospira Inc, A Pfizer Company
2/6/18Advanced PharmaPotassium Phosphate and Succinylcholine ChlorideDue to Lack of Sterility AssuranceAdvanced Pharma, Inc. d/b/a Avella of Houston
2/6/18PharMEDiumNorepinephrine Bitartrate added to Sodium ChlorideFound to exhibit a slight discoloration in the admixturePharMEDium Services, LLC
2/6/18LupinMibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg)Missing ExpiryLupin Pharmaceuticals Inc.
2/6/18Advanced PharmaNitroglycerin productsDue To Sub-PotencyAdvanced Pharma, Inc. d/b/a Avella of Houston
2/6/18Teva Pharmaceuticals USA, IncPaliperidone Extended-Release Tablets, 3mgDue to Dissolution Test FailureTeva Pharmaceuticals USA, Inc
2/6/18Advanced PharmaAll unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston locationPotential Inaccuracy of Latex Free Label ReferenceAvella Specialty Pharmacy
2/6/18HYDROmorphone, LevophedHydromorphone HCl, LevophedDue to Lack of Sterility AssuranceHospira, Inc.
2/6/18International Laboratories, LLCPravastatin Sodium TabletsLabeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tabletsInternational Laboratories, LLC
2/6/18Leader, Major, RugbyLiquid drug productsPossible contaminationCardinal Health
2/6/18GericareSterile Eye Irrigation SolutionPotential microbial contamination which compromises sterilityKareway Products Inc.
2/6/18PharMEDiumOxytocinSub-PotencyPharMEDium Services, LLC
2/6/18CenturionNinjacof and Ninjacof APotential contamination with Burkholderia cepaciaCenturion Labs
2/6/18Hospira, Inc.Vancomycin Hydrochloride for InjectionDue to the Presence of Particulate MatterHospira, Inc.
2/6/18Atlantic Pharmacy and CompoundingAll compounded injectable prescription medicationsLack of Sterility AssuranceVital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding
2/6/18Truxton IncorporatedAmitriptyline HCL Tablets, USP 50mg andPhenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mgLabel Mix-up ErrorC.O. Truxton, Inc.
2/6/18CaverfloNatural Herbal CoffeeUndeclared Active Pharmaceutical Ingredients and Undeclared MilkCaverflo.com
1/29/18LimbrelLimbrel, Limbrel 250, Limbrel 500Due to adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitisPrimus Pharmaceuticals, Inc.
1/25/18AuroMedicsLevofloxacin in 5% Dextrose Injection 250mg/50mLDue to the Presence of Particulate MatterAuroMedics Pharma LLC
1/24/18Basic DrugsSenna LaxativeDue to MislabelingMagno-Humphries Laboratories, Inc.
1/16/18NexteroneNexterone 150mg/100ml injectionDue to the Presence of Particulate MatterBaxter International Inc.
1/16/18NexteroneAmiodarone HClPresence of Particulate MatterBaxter International Inc
1/11/18PharMEDium Services, LLCCompounded injectablesLack of SterilityPharMEDium Services, LLC
1/11/18PharMEDium Services LLCVarious compounded drug products intended to be sterileLack of SterilityPharMEDium Services LLC
1/10/18International Laboratories, LLCClopidogrel Tablets USP, 75 mgDue to MislabelingInternational Laboratories, LLC
1/10/18AuroMedics Pharma LLCAmpicillin and Sulbactam for Injection USPPresence of Glass Particles in VialAuroMedics Pharma LLC
12/29/17Ridge Properties DBA Pain Relief NaturallyPain and itch relief productsManufacturing ConcernsRidge Properties DBA Pain Relief Naturally
12/29/17Fresenius Kabi USAMidazolam Injection, USP prefilled syringeMislabeledFresenius Kabi USA
12/29/17Greenstone LLCdiphenoxylate hydrochloride and atropine sulfate tablets, USPDue to Possible Sub Potent and Super Potent TabletsGreenstone LLC, a wholly owned subsidiary of Pfizer Inc.
12/29/17Sun PharmaRiomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mLMicrobial Contamination (Scopulariopsis brevicaulis)Sun Pharmaceutical Industries Ltd
12/29/17Pharmacist ChoiceAlcohol Prep PadsDue to Lack of Sterility AssuranceSimple Diagnostics
12/29/17Marmex CorpMale EnhancementUnapproved new drugMarmex Corp
12/29/17AuroMedics Pharma LLCPantoprazole Sodium for Injection 40 mg per vialContains glass particlesAuroMedics Pharma LLC
12/29/17AuroMedicsLinezolid InjectionWhite particulate matter that has been identified as moldAuroMedics Pharma
10/20/17SCA Pharmaceuticals LLCInjectable drugsLack of Sterility AssuranceSCA Pharmaceuticals LLC
10/19/17A1 SlimDietary Supplement A1 SlimUnapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramineKiriko, LLC
10/19/17A1Dietary Supplement A1 SlimUnapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramineKiriko, LLC
10/5/17BaxterINTRALIPID 20% IV Fat Emulsion, 100 mLProduct exposed to subfreezing temperaturesBaxter International Inc.

Below is a text analysis of the most common words used in the Recall Reason Description text above.

WordOccurrencesFrequencyRank
due909.5%1
sterility363.8%2
lack343.6%3
potential313.3%4
assurance262.7%5
detection252.6%6
presence252.6%6
contamination212.2%7
impurity202.1%8
particulate171.8%9
ndma151.6%10
nitrosodimethylamine141.5%11
microbial141.5%11
matter131.4%12
nmba121.3%13
ndea121.3%13
nitrosodiethylamine121.3%13
acid111.2%14
undeclared111.2%14
methyl101.1%15
mislabeling101.1%15
nitroso101.1%15
contain101.1%15
butyric91%16
amino91%16
product80.8%17
unapproved80.8%17
glass80.8%17
sildenafil80.8%17
tadalafil60.6%18
levels60.6%18
high60.6%18
label60.6%18
sibutramine60.6%18
possible60.6%18
may60.6%18
labeling50.5%19
incorrect50.5%19
ingredient50.5%19
material50.5%19
fda50.5%19
foreign50.5%19
drug50.5%19
tablets40.4%20
active40.4%20
amounts40.4%20
new40.4%20
above40.4%20
results40.4%20
manufacturing40.4%20
contains40.4%20
burkholderia40.4%20
mix40.4%20
trace40.4%20
found30.3%21
pseudomonas30.3%21
sub30.3%21
nonsterility30.3%21
test30.3%21
latex30.3%21
contaminated30.3%21
concerns30.3%21
microbiological30.3%21
mold30.3%21
controls30.3%21
bacteria30.3%21
ingredients30.3%21
non30.3%21
vials30.3%21
cepacia30.3%21
established30.3%21
tainted30.3%21
particles30.3%21
adverse30.3%21
hcl20.2%22
missing20.2%22
yeast20.2%22
level20.2%22
bacillus20.2%22
capsules20.2%22
reports20.2%22
event20.2%22
particulates20.2%22
reactions20.2%22
cracked20.2%22
small20.2%22
instructions20.2%22
eliquis20.2%22
error20.2%22
salmonella20.2%22
ibuprofen20.2%22
higher20.2%22
labeled20.2%22
dosing20.2%22
risk20.2%22
identified20.2%22
failure20.2%22
dissolution20.2%22
amount20.2%22
elevated20.2%22
desmethyl20.2%22
unexpected20.2%22
phenolphthalein20.2%22
marketed20.2%22
without20.2%22
potent20.2%22
specification20.2%22
sulfite20.2%22
potentially20.2%22
potency20.2%22
dosage20.2%22
practices20.2%22
sterile20.2%22
free20.2%22
hypersensitivity10.1%23
acute10.1%23
super10.1%23
carton10.1%23
empty10.1%23
mislabeled10.1%23
actual10.1%23
vial10.1%23
surface10.1%23
rim10.1%23
pneumonitis10.1%23
white10.1%23
subfreezing10.1%23
exposed10.1%23
methanol10.1%23
temperatures10.1%23
sequence10.1%23
flow10.1%23
clotting10.1%23
adequate10.1%23
visible10.1%23
scopulariopsis10.1%23
front10.1%23
sticker10.1%23
brevicaulis10.1%23
another10.1%23
inaccurate10.1%23
lead10.1%23
match10.1%23
misprinted10.1%23
cyclobenzaprine10.1%23
sodium10.1%23
amantadine10.1%23
usp10.1%23
drugs10.1%23
bupropion10.1%23
strength10.1%23
contained10.1%23
growth10.1%23
exhibit10.1%23
blood10.1%23
inaccuracy10.1%23
expiry10.1%23
admixture10.1%23
discoloration10.1%23
slight10.1%23
pravastatin10.1%23
reference10.1%23
declared10.1%23
hydrochloride10.1%23
issue10.1%23
ephedra10.1%23
liver10.1%23
function10.1%23
tests10.1%23
present10.1%23
analogues10.1%23
droppers10.1%23
herb10.1%23
banned10.1%23
anabolic10.1%23
steroids10.1%23
compromises10.1%23
derivatives10.1%23
quality10.1%23
milk10.1%23
pharmaceutical10.1%23
medicine10.1%23
cap10.1%23
peanut10.1%23
daily10.1%23
information10.1%23
defect10.1%23
aminobutyric10.1%23
process10.1%23
customer10.1%23
ordering10.1%23
system10.1%23
stated10.1%23
cereus10.1%23
circulans10.1%23
burr10.1%23
approved10.1%23
nda10.1%23
anda10.1%23
arrangement10.1%23
tablet10.1%23
preservative10.1%23
aeruginosa10.1%23
possibility10.1%23
electronic10.1%23
point10.1%23
rubber10.1%23
facility10.1%23
superpotency10.1%23
products10.1%23
methylnitrosobutyric10.1%23
called10.1%23
suturagel10.1%23
substance10.1%23
nitrosamine10.1%23
approval10.1%23
manufactured10.1%23
oos10.1%23
month10.1%23
stability10.1%23
time10.1%23
cgmp10.1%23
good10.1%23
outside10.1%23
required10.1%23
current10.1%23
concentration10.1%23
colloidal10.1%23
milliliters10.1%23
loads10.1%23
adulteration10.1%23
silicone10.1%23
described10.1%23
teaspoons10.1%23
cup10.1%23
provided10.1%23
marked10.1%23
contaminants10.1%23
brenneri10.1%23
indicative10.1%23
infusion10.1%23
safety10.1%23
patients10.1%23
nnitrosodimethylamine10.1%23
carcinogen10.1%23
fluroescens10.1%23
multivorans10.1%23
probable10.1%23
precipitate10.1%23
solution10.1%23
concentrations10.1%23
incorrectly10.1%23
stating10.1%23
stoppers10.1%23
hazard10.1%23
inr10.1%23
silver10.1%23
inaccurately10.1%23
reporting10.1%23
connector10.1%23
housing10.1%23
conditions10.1%23
veridate10.1%23
dispenser10.1%23
floating10.1%23
production10.1%23
wire10.1%23
slide10.1%23
expose10.1%23
connection10.1%23
low10.1%23

Leave a Reply

Your email address will not be published.