Drug Recall Notices

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

• 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)