Drug 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.
D-0045-2025
Product summary
- Event
- Event 95700
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25814 tablets
- Official record key
drug-enforcement:D-0045-2025
Official wording
Reason: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Code information: Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications