The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Drug Recall
Recall #D-0045-2025 · 11/05/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0045-2025
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Status
- Terminated
- Date Initiated
- 11/05/2024
- Location
- La Vergne, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25814 tablets
Reason for Recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
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.
Distribution Pattern
Nationwide in the US.
Other Recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
View all recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.