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Ó÷üëéá => Åãêëçìá óôï ÷þñï ôçò Õãåßáò => ÌÞíõìá îåêßíçóå áðü: Rose óôéò Ïêôùâñßïõ 14, 2019, 00:12:26
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https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
Drug Recalls
A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.
Show entries
Date Brand Name(s) Product Description Recall Reason Description Company Name
10/10/2019 Innoveix Pharmaceuticals, Inc. Injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2 Potential lack of sterility assurance Innoveix Pharmaceuticals, Inc.
09/25/2019 Apotex Corp. Ranitidine Tablets 75mg and 150mg Contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) Apotex Corp.
09/23/2019 Sandoz Inc. Ranitidine Hydrochloride Capsules Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Sandoz Inc.
09/19/2019 Torrent Pharma Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP Due to the Detection of N-Methylnitrosobutyric acid (NMBA) Torrent Pharmaceuticals Limited
09/16/2019 Macho MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Undeclared Tadalafil Fitoterapia USA Inc.
09/12/2019 Darmerica LLC Quinacrine Dihydrochloride, bulk API powder Label mix-up Darmerica LLC
09/12/2019 KRS Global Biotechnology Human Sterile Drug Products Lack of Sterility Assurance KRS Global Biotechnology
09/09/2019 Major Pharmaceuticals Milk of Magnesia Oral Suspension 2400 mg/30 ml Microbial Contamination Plastikon Healthcare
09/06/2019 Hospira Inc. Bacteriostatic Water for Injection Potential Lack of Sterility Assurance Hospira Inc.
09/05/2019 Natpara Parathyroid Hormone for Injection Potential presence of rubber particulate Takeda Pharmaceutical Company Limited
08/30/2019 AmEx Pharmacy Bevacizumab 1.25mg/0.05mL 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable Potential for non-sterility Pacifico National, Inc. dba AmEx Pharmacy
08/22/2019 Dechra Veterinary Products Veterinary ophthalmic drug products Due to concerns of QA controls in the manufacturing facility Altaire Pharmaceuticals, Inc.
08/15/2019 RELPAX RELPAX® (eletriptan hydrobromide) 40 mg tablets Microbiological Contamination Pfizer Inc
08/08/2019 TAT Balm, Naturally HL 4% Lidocaine topical cream & liquid gel products Microbiological Contamination and Superpotency Ridge Properties LLC DBA Pain Relief Naturally
07/24/2019 Herbal Doctor Remedies Drug products All products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP) Herbal Doctor Remedies
07/23/2019 Cadista Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg Due to out of specification (OOS) dissolution results at the 3-month stability time point Jubilant Cadista Pharmaceuticals Inc.
07/16/2019 Natural Ophthalmics, TRP/Target Up & Up Over-The-Counter Ophthalmic Products Due to lack of sterility assurance Altaire Pharmaceuticals, Inc.
07/16/2019 OCuSOFT Prescription (RX) and Over-the-Counter (OTC) Ophthalmic products Due to lack of sterility assurance Altaire Pharmaceuticals, Inc.,
07/15/2019 Altaire Pharmaceuticals, Inc. OTC and Rx Ophthalmic Products Due to lack of sterility assurance Altaire Pharmaceuticals Inc.
07/15/2019 Alvogen Fentanyl Transdermal System Due to Product Mislabeling Alvogen
07/15/2019 Legacy Losartan Potassium USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Legacy Pharmaceutical Packaging
07/15/2019 Equate and Support Harmony Over-the-Counter (OTC) drug products Potential for nonsterility Altaire Pharmaceuticals, Inc.
07/10/2019 CVS Health Multiple Ophthalmic Products Due to lack of assurance of sterility Altaire Pharmaceuticals, Inc
07/05/2019 Equate and Support Harmony Over-the-Counter (OTC) drug products Potential for nonsterility Altaire Pharmaceuticals, Inc.
07/03/2019 Walgreens Eye drops and ophthalmic ointments Potential for nonsterility Altaire Pharmaceuticals, Inc.
07/03/2019 Perrigo Ophthalmic ointments Potential for nonsterility Altaire Pharmaceuticals, Inc.
07/02/2019 Fresenius Kabi, Novaplus Fluorouracil Injection Potential for glass particulate Fresenius Kabi USA, LLC
06/28/2019 PharMEDium 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe The electronic customer ordering system stated it is sulfite-free, but the product contains sulfite. PharMEDium Services, LLC
06/26/2019 Macleods Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets Presence of NMBA impurity Macleods Pharmaceutical Limited
06/20/2019 Infusion Options Inc. All sterile products within expiry Lack of Sterility Assurance Infusion Options Inc.
06/18/2019 Premier Pharmacy Labs All Products Intended to be Sterile Lack of Sterility Assurance Premier Pharmacy Labs Inc
06/18/2019 RXQ Compounding LLC All sterile human and animal products within expiry. Lack of Sterility Process Assurance RXQ Compounding LLC
06/11/2019 GSMS Inc. Losartan potassium tablets Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Teva Pharmaceuticals USA, Inc.
05/29/2019 Pecgen DMX, PECGEN DMX, 16 oz, liquid cough syrup Incorrect dosage on label NOVIS PR LLC
05/28/2019 Heritage Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) Sterility Failure Heritage Pharmaceuticals Inc.
05/23/2019 Pharm D Solutions Sterile Compounded Drug Products Lack of sterility assurance Pharm D Solutions, LLC
05/12/2019 Promacta Promacta 12.5 mg oral suspension Due to Potential Peanut Contamination Novartis
05/03/2019 WP Westminster, more Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms Due to detection of NDEA (N-Nitrosodiethylamine) Impurity ScieGen Pharmaceuticals, Inc
05/03/2019 Par Pharmaceutical Mycophenolate Mofetil for injection Foreign Material Par Pharmaceutical, Inc.
05/03/2019 Heritage Losartan Potassium Tablets USP Lack of sterility Vivimed
05/02/2019 Endo Pharmaceuticals Robaxin® (methocarbamol tablets, USP) 750mg Tablets Incorrect Daily Dosing Information on Label Endo Pharmaceuticals
04/30/2019 Sagent Pharmaceuticals Ketorolac Tromethamine Injection Lack of Sterility Sagent Pharmaceuticals
04/29/2019 AmEx Pharmacy Bevacizumab 1.25mg/0.05mL 31G Injectable Product Defect AmEx Pharmacy
04/26/2019 GSMS Incorporated Losartan Potassium 25 mg and 100 mg Tablets USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Teva Pharmaceuticals USA, Inc
04/18/2019 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals Limited
04/12/2019 Platinum 40000 Aphrodisiac capsules Unapproved Ingredient SD Imports
03/28/2019 Legacy Losartan Potassium USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Legacy Pharmaceutical Packaging
03/25/2019 Leopard Dietary Supplement Undeclared Sildenafil USA LESS
03/20/2019 DG™/health NATURALS baby Cough Syrup + Mucus Potential to be contaminated with Bacillus cereus/ Bacillus circulans Kingston Pharma, LLC
03/19/2019 Legacy Losartan Potassium USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Legacy Pharmaceutical Packaging
03/18/2019 Mylan Levoleucovorin Injection, 250 mg/25 mL Presence of particulate matter Mylan Institutional LLC
03/15/2019 Legacy Losartan Potassium USP Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Legacy Pharmaceutical Packaging
03/15/2019 Hospira Sodium bicarbonate injection USP Presence of Particulate Matter Hospira, Inc.
03/13/2019 Stokes Healthcare Pilocarpine opthalmic solution Due to a High Level of Preservative Stokes Healthcare, Inc.
03/07/2019 Aurobindo Pharma USA, Inc. Valsartan Tablets USP Due to detection of N-Nitrosodiethylamine (NDEA) American Health Packaging
03/06/2019 Life-Line tm Additive for human drinking water Contaminated with Pseudomonas aeruginosa McDaniel Life-Line LLC
03/01/2019 Torrent Pharma Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals Limited
03/01/2019 Aurobindo, Acetris Valsartan and Amlodipine and Valsartan tablets Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity AurobindoPharma USA, Inc.
03/01/2019 Apotex Corp. Drospirenone and Ethinyl Estradiol Tablets, USP Possibility of Missing/Incorrect Tablet Arrangement Apotex Corp.
02/28/2019 Camber Pharmaceuticals, Inc. Losartan Tablets USP 25 mg, 50 mg, and 100 mg Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Camber Pharmaceuticals, Inc.
02/26/2019 ChemoLock and ChemoClave Vial Spikes Due to the Potential for Burr Particulate ICU Medical, Inc.
02/25/2019 Golean Detox Dietary Supplement for Weight Loss Mislabeling Golean Detox USA
02/22/2019 Macleods Losartan Potassium/Hydrochlorothiazide Combination Tablets Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Macleods Pharmaceuticals Limited
02/08/2019 McDaniel Life-Line Indian Herb (topical) Unapproved drug. Marketed without an approved NDA/ANDA McDaniel Life-Line LLC
02/04/2019 Dr. Reddy’s Laboratories Ltd. Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection) Mislabeling Dr. Reddy’s Laboratories Ltd.
01/29/2019 CVS, Equate Oral ibuprofen Higher Concentration of Ibuprofen Tris Pharma, Inc.
01/22/2019 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USP Lack of Sterility Torrent Pharmaceuticals Limited
01/18/2019 Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Irbesartan and Irbesartan HCTZ Tablets Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
01/08/2019 Sun Pharma Vecuronium Bromide for Injection Potential Foreign Material Sun Pharmaceutical Industries, Inc
01/08/2019 Rhino Rhino 5K capsules Undeclared Sildenafil and Tadalafil Happy Together, Inc.
01/05/2019 Lupin Pharmaceuticals, Inc. Ceftriaxone for Injection, USP Foreign Material Lupin Pharmaceuticals, Inc.
01/03/2019 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP Due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) Torrent Pharmaceuticals Limited
01/02/2019 Lubrisine Eye Drops Sterility Concerns and Undeclared Colloidal Silver Results RNA LLC
12/31/2018 Aurobindo Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Aurobindo Pharma USA, Inc.
12/20/2018 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Torrent Pharmaceuticals Limited
12/19/2018 Terrific Care LLC dba MedEx Supply Roche CoaguChek test strips Inaccurately reporting high INR test results Terrific Care, LLC. / Medex Supply Dist, Inc.
12/17/2018 Envoachem Pharmaceuticals Dyural-40 and Dyural-80 Due to Latex Hazard Asclemed USA Inc dba Envoachem Pharmeceuticals
12/06/2018 Family Wellness, CVS, Equate Infants’ Ibuprofen Due to Potential Higher Concentrations of Ibuprofen Tris Pharma
12/04/2018 Mylan Valsartan-containing products Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Mylan Pharmaceuticals
11/27/2018 Teva Pharmaceuticals Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Teva Pharmaceuticals
11/21/2018 Fresenius Kabi Sodium 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 vial Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex Fresenius Kabi USA
11/12/2018 Oscor Temporary Bipolar Pacing Lead, Model TB Connector cap housing may slide and potentially expose the connection wire Oscor Inc.
11/09/2018 Losartan Potassium Hydrochlorothiazide Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Sandoz Inc
11/07/2018 Puriton Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle Due to Non-Sterile Production Conditions Kadesh Inc.
11/02/2018 ORTHO-NOVUM ORTHO-NOVUM 1/35 and 7/7/7 Due to Incorrect Veridate Dispenser Instructions Janssen Pharmaceuticals, Inc.
10/29/2018 Aurobindo Pharma Limited Irbesartan Drug Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Aurobindo Pharma Limited
10/22/2018 Promise Pharmacy Prednisolone and Gatifloxacin Ophthalmic Solution Due to Small Particulate Floating in the Solution Promise Pharmacy
10/18/2018 Zero Xtreme Dietary Supplement for Weight Loss Due to Presence of Undeclared Sibutramine Fat Burners Zone
10/10/2018 ReGen Series All ReGen Series products Adverse reactions Liveyon, LLC
10/10/2018 Sprayology Homeopathic Aqueous-Based Medicines Possible microbial contamination Eight and Company LLC, dba Sprayology
09/13/2018 NeoRelief Muscle Due to Possible Microbial Contamination BioLyte Laboratories
09/10/2018 Pharm D Solutions Compounded drugs Lack of Sterility Pharm D Solutions LLC
09/07/2018 SCA Pharmaceuticals Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag Due to Presence of Precipitate SCA Pharmaceuticals LLC (“SCA Pharma”)
09/07/2018 Camber Pharmaceuticals Montelukast Sodium Tablets, USP 10mg Mislabeling Camber Pharmaceuticals, Inc
09/06/2018 Beaumont Bio Med Homeopathic Homeopathic oral sprays Due to Possible Microbial Contamination Beaumont Bio Med, Inc.
08/29/2018 CVS, Rhinall, Humist, more Nasal Products and Baby Oral Gels Microbial Contamination Product Quest Manufacturing LLC
08/29/2018 Neuroveen, Respitrol, Thyroveev, Compulsin Homeopathic Medicines Due to Possible Microbial Contamination HelloLife, Inc.
08/28/2018 Dr. King’s Homeopathic products for human and animal use Microbial Contamination King Bio
08/28/2018 Children’s Advil Ibuprofen Oral Suspension Dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL) Pfizer, Inc.
08/27/2018 Accord Hydrochlorothiazide Tablets USP 12.5 mg Due to Labeling Mix-up Accord Healthcare Inc.
08/24/2018 Torrent Pharmaceuticals Limited Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets Impurity Torrent Pharmaceuticals Limited
08/24/2018 KB, DK, more Homeopathic products Microbial contamination King Bio
08/17/2018 Torrent Valsartan/Amlodipine/HCTZ Tablets Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals
08/16/2018 Blissful Remedies Products Containing Kratom Due to High Microbial Loads Contamination World Organix, LLC
08/14/2018 Kratom Powder Capsule Kratom Powder Capsule Potential to be contaminated with Salmonella Blissful Remedies
08/10/2018 Westminster Pharmaceuticals, LLC Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg Due to Risk of Adulteration Westminster Pharmaceuticals, LLC
08/09/2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity Camber Pharmaceuticals, Inc.
08/08/2018 Actavis Valsartan and Valsartan Hydrochlorothiazide Tablets Impurity Teva Pharmaceuticals USA
08/08/2018 CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination Product Quest Manufacturing (“Product Quest”)
07/31/2018 Auromedics Piperacillin and Tazobactam for injection, USP 3.375 g Due to Presence of Particulates Identified as Glass and Silicone Material AuroMedics Pharma
07/28/2018 Ranier's RX Laboratory Compounded drug products Due to Lack of Sterility Assurance Ranier's RX Laboratory
07/20/2018 Dr. King’s, Dr. King’s Aquaflora Homeopathic liquids: Candida liquid, lymph detox liquid, baby teething liquid microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans. King Bio Inc.
07/18/2018 Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
07/16/2018 Major Pharmaceuticals Valsartan tablets, 80mg USP and 160 mg USP may contain the probable carcinogen Nnitrosodimethylamine (NDMA) Major Pharmaceuticals
07/02/2018 Fagron Sterile Services Neostigmine Methylsulfate 5 mL Syringes Mislabeling Fagron Sterile Services
06/27/2018 Hospira Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial Adverse event reports indicative of infusion reactions Hospira Inc.
06/21/2018 Gaia Ethnobotanical Kratom Products Salmonella Gaia Ethnobotanical, LLC
06/04/2018 Hospira Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use cartridge Syringe System Potential of Foreign Material Hospira Inc.
05/31/2018 Apotex Fluticasone Propionate Nasal Spray Small Glass Particles Apotex Corp.
05/31/2018 HeartMate 3 Left Ventricular Assist Device potential safety risk to patients, such as low blood flow or clotting. Abbott
05/29/2018 Taytulla Birth control capsules Due to Out of Sequence Capsules Allergan
05/25/2018 X-Jow, Acne Shave Pain Gel, Moisturizer, Shave Cream Bacteria Shadow Holdings
05/23/2018 Ethanol Extraction/Lake Michigan Distilling Company, LLC 95% Ethyl Alcohol product Methanol Lake Michigan Distilling Company, LLC dba Ethanol Extraction
05/18/2018 MBI Distributing, Inc. Various Homeopathic Products Lack of Adequate Controls MBI Distributing, Inc.
05/17/2018 7K and Poseidon 7K and Poseidon 4500 Dietary Supplements Undeclared Sildenafil and Tadalafil Shoreside Enterprises
05/14/2018 AuroMedics Pharma LLC Piperacillin and Tazobactam for injection, USP 3.375 g/vial Due to Presence of Glass Particulates AuroMedics Pharma LLC
05/14/2018 AuroMedics Pharma LLC Ampicillin and Sulbactam for Injection USP, 3 grams/ Single-Dose vial Visible Particulate Matter AuroMedics Pharma LLC
05/14/2018 Apotex Corporation Piperacillin and Tazobactam for Injection Ingredient Level Apotex Corporation
04/13/2018 AMA Wholesale Inc. Rhino 69 Extreme 50000 capsules Undeclared tadalafil AMA Wholesale Inc.
04/11/2018 Premier Pharmacy Labs Sterile Injectable Drug Products Due to a Potential Lack of Sterility Assurance Premier Pharmacy Labs
04/03/2018 PASTA DE LASSAR ANDROMACO Pasta De Lassar Andromaco Skin Protectant Due to Potential Contamination of high levels of yeast, mold, and bacteria MarcasUSA, LLC
04/03/2018 PASTA DE LASSAR ANDROMACO Pasta De Lassar Andromaco Skin Protectant Due to Potential Contamination of high levels of yeast, mold, and bacteria MarcasUSA, LLC
03/22/2018 BD Vacutainer tubes Inaccurate lead test results BD
03/16/2018 Bayer Alka-Seltzer Plus Mislabeling-The ingredients on the front sticker may not match the actual product in the carton Bayer
03/06/2018 Sagent Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results Sagent Pharmaceuticals
03/05/2018 Hospira, Inc. Hydromorphone HCL Injection, USP Due to The Potential for Empty or Cracked Glass Vials Hospira, Inc.
02/23/2018 Hospira, Novaplus Labetalol Hydrochloride Injection, USP Due to Potential Of Cracked Glass At The Rim Surface Of The Vials Hospira, Inc.
02/15/2018 AVpak Acyclovir Tablet, USP, 400mg, 50ct Unit Dose Due to Product Mix-up Apace Packaging LLC
02/09/2018 Bella Pharma All lots of unexpired sterile drug products Lack of Sterility Bella Pharmaceuticals, Inc.
02/09/2018 LaBri’s Body Health Dietary Supplement Mislabeling Envy Me
02/08/2018 Doctor Manzanilla Allergy, cough medicine Burkholderia Cepacia Mid Valley Pharmaceutical
02/08/2018 Man of Steel Man of Steel 1 and Man of Steel 2 Due to Presence of Undeclared Sildenafil Man of Steel
02/08/2018 Edex Alprostadil for injection Potential Lack of Sterility Assurance Endo Pharmaceuticals Inc.
02/08/2018 Astrazeneca professional (physician) sample BRILINTA (ticagrelor) 90mg tablets Another medicine present Astrazeneca
02/08/2018 Uproar, Cummor, Zrect, Monkey Business and others Dietary Supplement Undeclared Active Ingredients tadalafil, sildenafil and analogues Organic Herbal Supply, Inc.
02/08/2018 Hospira, Inc. Vancomycin Hydrochloride for injection Due to the Presence of Particulate Matter Hospira, Inc.
02/08/2018 Genentech Activase® (alteplase) 100mg vials Due to Lack of Sterility Assurance Genentech
02/08/2018 Amneal Pharmaceuticals LLC Lorazepam Oral Concentrate, USP 2mg/mL Due to Misprinted Dosing Droppers Amneal Pharmaceuticals LLC
02/08/2018 Baxter intravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USP Labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets Baxter International Inc.
02/08/2018 Rugby Diocto Liquid and Diocto Syrup Potential contamination with Burkholderia cepacia Rugby® Laboratories
02/08/2018 Hyland's Baby teething tablets and Nightime teething tablets Mislabeling Standard Homeopathic Company
02/08/2018 Bristol-Myers Squibb Eliquis (apixaban) 5 mg Tablets Potential Labeling Issue Bristol-Myers Squibb
02/08/2018 Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient Lucky Mart Inc.
02/08/2018 Tetracycline-ABC, Tetrastem, Diabecline and more topical products Manufacturing Practices Phillips Company
02/08/2018 X-Gen Ibuprofen Lysine Injection, 20 mg/2 mL Some of the vials have been found to contain particulate matter Exela Pharma Sciences, LLC
02/08/2018 The Green Herb AL-ER-G dietary supplement Presence of Ephedra Herb, an FDA banned ingredient MusclMasster LLC
02/08/2018 Cantrell Drug Company All unexpired sterile drug syringes and IV bags Due to Lack of Sterility Assurance Cantrell Drug Company
02/08/2018 Alvogen Clindamycin Injection USP Due to Lack of Sterility Assurance Alvogen
02/08/2018 Hospira, Inc. 25% Dextrose Injection, USP (Infant) Due to the Presence of Particulate Matter Hospira, Inc.
02/08/2018 Synergy Rx Pharmacy Non-sterile drug products Lack of Quality Assurance Synergy Rx Pharmacy
02/08/2018 Apexxx Dietary Supplement Due to presence of Sildenafil Nuway Distributors
02/08/2018 ICU Medical, Inc. 0.9% Sodium Chloride Injection, USP 1000 mL Due to the Presence of Particulate Matter ICU Medical, Inc.
02/08/2018 Fagron Sterile Services Succinylcholine Chloride 20mg/mL Lack of Sterility Assurance Fagron Sterile Services
02/08/2018 Andropharm Sten Z and M1 Alphas capsules Contain derivatives of anabolic steroids Andropharm
02/08/2018 C.O. Truxton, Inc. Phenobarbital Tablets, USP, 15 mg Due to Labeling Error on Declared Strength C.O. Truxton, Inc.
02/08/2018 LaBri's Body Health Dietary Supplement Due to presence of Sibutramine EZ Weight Loss TX
02/08/2018 Super Panther 7K Dietary Supplement Unapproved new drug Ultra Shop Supplement
02/07/2018 PharMEDium Potassium Phosphate and Succinylcholine Chloride Intravia Bags Due to Lack of Sterility Assurance PharMEDium Services
02/07/2018 Synergy Rx Pharmacy Human Chorionic Gonadotropin (HCG)for injection Due to Lack of Sterility Assurance Synergy Rx Pharmacy
02/07/2018 Bristol-Myers Squibb Eliquis (apixaban) 5 mg Tablets Labeling Bristol-Myers Squibb
02/07/2018 Ultra-Sten, D-Zine Marketed as a dietary supplement Unapproved drugs Hardcore Formulations
02/07/2018 Apace Packaging LLC Cyclobenzaprine HCl Tablet and Amantadine HCl Capsule Cyclobenzaprine HCL may contain Amantadine HCL Capsules Apace Packaging LLC
02/07/2018 Isomeric Pharmacy Solutions Multiple compounded sterile products Due to Lack of Sterility Assurance Isomeric Pharmacy Solutions
02/06/2018 Hospira 8.4% Sodium Bicarbonate Injection, USP, NeutTM (Sodium Bicarbonate 4% additive solution), QUELICINTM (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due to microbial growth Hospira Inc, A Pfizer Company
02/06/2018 Advanced Pharma Potassium Phosphate and Succinylcholine Chloride Due to Lack of Sterility Assurance Advanced Pharma, Inc. d/b/a Avella of Houston
02/06/2018 PharMEDium Norepinephrine Bitartrate added to Sodium Chloride Found to exhibit a slight discoloration in the admixture PharMEDium Services, LLC
02/06/2018 Lupin Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Missing Expiry Lupin Pharmaceuticals Inc.
02/06/2018 Advanced Pharma Nitroglycerin products Due To Sub-Potency Advanced Pharma, Inc. d/b/a Avella of Houston
02/06/2018 Teva Pharmaceuticals USA, Inc Paliperidone Extended-Release Tablets, 3mg Due to Dissolution Test Failure Teva Pharmaceuticals USA, Inc
02/06/2018 Advanced Pharma All unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location Potential Inaccuracy of Latex Free Label Reference Avella Specialty Pharmacy
02/06/2018 HYDROmorphone, Levophed Hydromorphone HCl, Levophed Due to Lack of Sterility Assurance Hospira, Inc.
02/06/2018 International Laboratories, LLC Pravastatin Sodium Tablets Labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets International Laboratories, LLC
02/06/2018 Leader, Major, Rugby Liquid drug products Possible contamination Cardinal Health
02/06/2018 Gericare Sterile Eye Irrigation Solution Potential microbial contamination which compromises sterility Kareway Products Inc.
02/06/2018 PharMEDium Oxytocin Sub-Potency PharMEDium Services, LLC
02/06/2018 Centurion Ninjacof and Ninjacof A Potential contamination with Burkholderia cepacia Centurion Labs
02/06/2018 Hospira, Inc. Vancomycin Hydrochloride for Injection Due to the Presence of Particulate Matter Hospira, Inc.
02/06/2018 Atlantic Pharmacy and Compounding All compounded injectable prescription medications Lack of Sterility Assurance Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding
02/06/2018 Truxton Incorporated Amitriptyline HCL Tablets, USP 50mg andPhenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Label Mix-up Error C.O. Truxton, Inc.
02/06/2018 Caverflo Natural Herbal Coffee Undeclared Active Pharmaceutical Ingredients and Undeclared Milk Caverflo.com
01/29/2018 Limbrel Limbrel, Limbrel 250, Limbrel 500 Due to adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis Primus Pharmaceuticals, Inc.
01/25/2018 AuroMedics Levofloxacin in 5% Dextrose Injection 250mg/50mL Due to the Presence of Particulate Matter AuroMedics Pharma LLC
01/24/2018 Basic Drugs Senna Laxative Due to Mislabeling Magno-Humphries Laboratories, Inc.
01/16/2018 Nexterone Nexterone 150mg/100ml injection Due to the Presence of Particulate Matter Baxter International Inc.
01/16/2018 Nexterone Amiodarone HCl Presence of Particulate Matter Baxter International Inc
01/11/2018 PharMEDium Services, LLC Compounded injectables Lack of Sterility PharMEDium Services, LLC
01/11/2018 PharMEDium Services LLC Various compounded drug products intended to be sterile Lack of Sterility PharMEDium Services LLC
01/10/2018 International Laboratories, LLC Clopidogrel Tablets USP, 75 mg Due to Mislabeling International Laboratories, LLC
01/10/2018 AuroMedics Pharma LLC Ampicillin and Sulbactam for Injection USP Presence of Glass Particles in Vial AuroMedics Pharma LLC
12/29/2017 Ridge Properties DBA Pain Relief Naturally Pain and itch relief products Manufacturing Concerns Ridge Properties DBA Pain Relief Naturally
12/29/2017 Fresenius Kabi USA Midazolam Injection, USP prefilled syringe Mislabeled Fresenius Kabi USA
12/29/2017 Greenstone LLC diphenoxylate hydrochloride and atropine sulfate tablets, USP Due to Possible Sub Potent and Super Potent Tablets Greenstone LLC, a wholly owned subsidiary of Pfizer Inc.
12/29/2017 Sun Pharma Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL Microbial Contamination (Scopulariopsis brevicaulis) Sun Pharmaceutical Industries Ltd
12/29/2017 Pharmacist Choice Alcohol Prep Pads Due to Lack of Sterility Assurance Simple Diagnostics
12/29/2017 Marmex Corp Male Enhancement Unapproved new drug Marmex Corp
12/29/2017 AuroMedics Pharma LLC Pantoprazole Sodium for Injection 40 mg per vial Contains glass particles AuroMedics Pharma LLC
12/29/2017 AuroMedics Linezolid Injection White particulate matter that has been identified as mold AuroMedics Pharma
10/20/2017 SCA Pharmaceuticals LLC Injectable drugs Lack of Sterility Assurance SCA Pharmaceuticals LLC
10/19/2017 A1 Slim Dietary Supplement A1 Slim Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine Kiriko, LLC
10/19/2017 A1 Dietary Supplement A1 Slim Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine Kiriko, LLC
10/05/2017 Baxter INTRALIPID 20% IV Fat Emulsion, 100 mL Product exposed to subfreezing temperatures Baxter International Inc.