Class III
Terminated
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.
This recall has been terminated (originally issued November 20, 2024).
- Recall Initiated
- November 5, 2024
- Posted
- November 20, 2024
- Recall Number
- D-0045-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25814 tablets
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Distribution
Nationwide in the US.
Lot / Code Info
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
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