Product: Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Reason for recall: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Recall initiated: 20241105
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated