FDA recall D-0653-2022

The Harvard Drug Group · Class II · drug

Product

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

Distribution

Nationwide within USA

Key facts

Status: Terminated
Initiation date: 2022-02-24
Report date: 2022-03-23
Termination date: 2023-07-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2022