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Class III Recall
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Classification
Class III
Status
Terminated
Lot
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Date
2024-11-20
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.