Drug Recall Notices

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

• 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)
• Amlodipine/Valsartan Tablets USP, Valsartan/HCTZ Tablets, USP and Valsartan Tablets USP by Aurobindo: 80 Lots Recalled Due to Detection of NDEA (N-Nitrosodiethylamine) Impurity (12/31/18)
• FDA Alerts Health Care Professionals & Patients Not to Use Drug Products Intended to be Sterile from Promise Pharmacy (12/10/18)
• Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen (12/5/18)
• Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets (11/27/18)
• Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (11/20/18)
• Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex (11/20/18)
• FDA Alerts Health Care Professionals and Patients Not to Use Sterile Drug Products from Pharm D Solutions (11/20/18)
• Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API) (11/8/18)
• Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions (11/2/18)
• Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API) (10/30/18)
• Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution (10/22/18)
• Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series Product, Manufactured by Genetech, Inc. (10/10/18)
• RXQ Compounding - Voluntary Recall of 1 Lot of Lidocaine 1% and Epinephrine Due to Possible Sub-Therapeutic Levels (10/4/18)
• Silver Star Brands - Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination (10/3/18)
• Endo Pharmaceuticals - Voluntary Nationwide Recall of Robaxin 750 mg Tablets 100 Count Bottles Due to Incorrect Daily Dosing Info on Label (9/28/18)
• Pharm D Solutions, LLC - Recall of All Sterile Compounded Drugs (9/10/18)
• Homeopathic Aqueous/Alcohol-Based Medicines by Beaumont Bio Med: Recall - Due to Possible Microbial Contamination (9/5/18)
• Recall of Montelukast Tablets by Camber Pharmaceuticals (8/31/18)
• District Court Orders Permanent Injunction Against Companies Selling Sexual Enhancement Products Containing Undisclosed Drugs (8/30/18)
• Alcon Voluntary Global Market Withdrawal of CyPass Micro-Stent (8/29/18)
• Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin (8/29/18)
• SCA Pharmaceuticals - Drug Recall  (8/27/18)
• SCA Pharmaceuticals - Drug Recall  (6/18/18)
• Medline Remedy Essentials No-Rinse Cleansing Foam - Recall (5/25/18)
• Compass Health Brands Recalls CPAP Mask Cushion Devices (5/22/18)
• Coastal Meds - Drug Recall (4/13/18)
• Premier Pharmacy Labs - Drug Recall (4/11/18)