Data Composite

Recall D-0045-2025

US Class III Terminated · initiated 2024-11-05

Recalling firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, TN

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.

Reason for recall

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

← All recalls