FDA recall D-0045-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class III · drug

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.

Distribution

Nationwide in the US.

Key facts

Status: Terminated
Initiation date: 2024-11-05
Report date: 2024-11-20
Termination date: 2025-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0045-2025