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.
FDA recall notice · announced November 20, 2024 · The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Notes
Distribution: Nationwide in the US.
Lot/code information: Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Quantity: 25814 tablets
Status: Terminated
Products in this recall event:
- 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 (D-0045-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.