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.
Reported: November 20, 2024 Initiated: November 5, 2024 #D-0045-2025
Product Description
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.
Details
- Units Affected
- 25814 tablets
- Distribution
- Nationwide in the US.
- Location
- La Vergne, TN
Frequently Asked Questions
What product 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.. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 25814 tablets.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 20, 2024. Severity: Low. Recall number: D-0045-2025.
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