Drug Recall Notices

Below are recent prescription drug/device recall notices provided to the Board by the FDA (Food & Drug Administration).

• Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity (6/1/20)
• Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA) (5/28/20)
• Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems (4/24/20)
• Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples (4/20/20)
• Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications (4/16/20)
• International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A (4/15/20)
• Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA (4/15/20)
• FDA Requests Removal of All Ranitidine (Zantac) Products Nationwide (4/1/20)
• Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates (3/5/20)
• American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity (2/27/20)
• Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing (2/21/20)
• FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility (1/17/20)
• Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles (1/13/20)
• Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity (1/8/20)
• Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences (1/8/20)
• Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) (1/7/20)
• Mavidon Issues Voluntary Worldwide Recall of all Manufactured Products Due to Burkholderia cepacia Contamination (12/23/19)
• Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination (12/18/19)
• Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity (11/12/19)
• Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products (11/1/19)
• Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance (10/25/19)
• Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) (10/25/19)
• Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance (10/10/19)
• Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product (9/25/19)
• Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product (9/23/19)
• Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP (9/23/19)
• Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error (9/12/19)
• KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (9/12/19)
• The Metrix Company of Dubuque, Iowa is Recalling Specific Lots of the Empty IV Flexible Containers (Bag) Marketed Under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix Names, Due to the Potential for Leaking of the IV Bag at the Chamber Divider Rod (9/10/19)
• Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL due to Microbial Contamination (9/9/19)
• Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance (9/6/19)
• Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate (9/5/19)
• FDA requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks (8/27/19)
• Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of RELPAX® (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products (8/15/19)
• Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results (7/23/19)
• Bayer Issues Voluntary Recall of Two Lots of Kogenate® FS Antihemophilic Factor (Recombinant) in the United States (7/19/19)
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens (7/3/19)
• Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate (7/2/19)
• Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide Combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg due to detection of NMBA (6/26/19)
• Infusion Options Inc. Issues Voluntary Nationwide Recall of All Lots of All Sterile Products Due to Lack of Assurance of Sterility (6/18/19)
• RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (6/18/19)
• Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (6/18/19)
  
• Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc. (6/11/19)
• FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables (6/7/19)
• Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) as a Result of a Sterility Test Failure (5/28/19)
• Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility Assurance (5/24/19)
• Norbrook Laboratories Limited Recalls Veterinary Products to Provide Sterility Assurance (5/24/19)
• Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension Due to Potential Peanut Contamination (5/11/19)
• Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity (5/3/19)
• Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted Product (5/1/19)
• Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance (4/30/19)
• Norbrook Laboratories Limited Expands Recall of Veterinary Products (4/29/19)
• AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System (4/29/19)
• Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply (4/29/19)
• Alvogen Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling (4/19/19)
• Torrent Pharmaceuticals Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP (4/18/19)
• Atlas Pharmaceuticals - Voluntary Recall of Metronidazole Tablets  (4/11/19)
• Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk (3/7/19)
• American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity (3/7/19)
• Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement (3/4/19)
• Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP (3/1/19)
• FDA Update on Three Recent MedWatch Safety Alert Recalls: on Angiotensin II Receptor Blocker Including Valsartan and Losartan (3/1/19)
• Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical (2/28/19)
• Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium / Hydrochlorothiazide Combination Tablets (2/22/19)
• Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling (2/4/19)
• Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers (2/4/19)
• FDA Warns Compounders Not to Use Glutathione from Letco Medical to Compound Sterile Drugs (2/1/19)
• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP (1/22/19)
• Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets (1/18/19)
• Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass (1/8/19)
• Ceftriaxone for Injection by Lupin Pharmaceuticals: Recall – Due to Visual Grey Particulate Matter in Reconstituted Vials (1/8/19)