The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Br…
- Recall date
- November 5, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0045-2025
- FDA classification
- Class III
- Brand / firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Sold / distributed
- Nationwide in the US.
Why it was recalled
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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