FDA Drug Recalls

Spectrum Laboratory Products, Inc. has issued a voluntary recall of its Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API), Lot number LP5003, Expiration date 12/2020, due to the product being discolored. The user-level recall was initiated after consumer complaints of the products being discolored. Risk Statement Epinephrine is used to treat critical life-threatening conditions that …

Spectrum Laboratory Products, Inc. Announces a Voluntary Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Product Discoloration Read More »

GFA Production (Xiamen) Co., Ltd issues a nationwide voluntary recall of Asy Care First Aid Burn Cream and First Aid Kits due to microbial contamination. The consumer-level recall was initiated after FDA testing revealed the presence of Bacillus licheniformis and Bacillus sonorensis in the products. Consumers can identify these products with their 0.9 g single-use …

GFA Production (Xiamen) Co., Ltd. Recalls Asy Care First Aid® Burn Cream and First Aid Kits Because of Microbial Contamination Read More »

Lupin Pharmaceuticals is issuing a voluntary nationwide recall of four lots of Quinapril tablets due to the potential presence of an N-Nitroso-Quinapril impurity. N-Nitroso-Quinapril is a nitrosamine impurity identified as a probable human carcinogen based on laboratory testing. The recall was initiated after recent testing confirmed that the level of N-Nitroso-Quinapril impurity in the affected …

Lupin Pharmaceuticals, Inc. Recalls Four Lots of Quinapril Tablets as They Could Contain N-Nitroso-Quinapril Impurity Read More »

Accord Healthcare Inc. has issued a voluntary nationwide recall of a single lot of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial due to a product mix-up. The affected lot # R2200232 was distributed in cartons with an expiry date of 01/2025. The consumer-level recall was initiated after a hospital reported that …

Accord Healthcare Inc. Voluntarily Recalls Daptomycin for Injection 500 mg/vial and Injection 350 mg/vial Due to Product Mix-Up Read More »

Hospira, Inc. has issued a voluntary nationwide recall of one lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, due to the presence of visible glass particulates observed in multiple vials from one batch. The user level recall affects lot 33045BA, distributed nationwide to wholesalers, distributors, and hospitals throughout the United States and Puerto Rico between June …

Hospira, Inc. Recalls One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial Because It Contains Visible Glass Particulates Read More »

Exela Pharma Sciences, LLC, expands its recall of Sodium Bicarbonate Injection, USP 8.4%, 50 mEq/50 mL Vial, 20-Count Carton with 10 Lots. The ongoing recall which affected forty-nine (49) lots now adds fourteen (14) more lots bringing the total number of recalled lots to sixty-three (63). The 14 more lots of Sodium Bicarbonate Injection, USP, …

Exela Pharma Sciences, LLC Expands Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage Read More »