FDAHealthNovember 5, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Bruns
⚠️ Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 5, 2024
Nationwide in the US.
What's affected?
- 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.
- Lot code
- T04888
Additional details
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 25814 tablets.
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