Αποστολέας Θέμα: Drug Recalls  (Αναγνώστηκε 31 φορές)

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Drug Recalls
« στις: Οκτώβριος 14, 2019, 00:12:26 »
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.

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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.
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