FDA: Drug Recalls Class II

FDA Class II Drug Recall - Semaglutide

The FDA has announced a Class II drug recall initiated voluntarily by Harbin Jixianglong Biotech Co., Ltd. of China for Semaglutide intended for compounding use. The recall is due to CGMP deviations, specifically failing to complete process validation and bacterial endotoxin method validation before distribution.

FDA Class II Recall of Midodrine Hydrochloride Tablets

The FDA has announced an ongoing Class II recall for Midodrine Hydrochloride Tablets, USP, 5 mg, initiated by The Harvard Drug Group LLC due to inadequately sealed blister packaging. The recall affects approximately 8,892 cartons distributed nationwide.

FDA Class II Recall for BZK PADS

The FDA has initiated a Class II recall for BZK PADS (Benzalkonium Chloride) manufactured by Dynarex Corporation, distributed by ACME UNITED CORPORATION. The recall is due to CGMP deviations and is ongoing nationwide.

FDA Class II Drug Recall: Acme United Corporation

The FDA has announced an ongoing Class II drug recall initiated by Acme United Corporation for Med Nap BZK Antiseptic Towelettes. The recall is due to CGMP deviations and affects nationwide distribution within the United States.

Icosapent Ethyl Capsules Class II Recall

The FDA is reporting an ongoing Class II recall for Icosapent Ethyl Capsules initiated by Zydus Pharmaceuticals (USA) Inc. The recall is due to the presence of red dots inside capsules and melted capsules caused by oxidized Icosapent ethyl, the active ingredient. Approximately 60,541 bottles are affected.