The Harvard Drug Group recalls hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMA
Recalled March 23, 2022 · FDA recall D-0653-2022 · The Harvard Drug Group
Hazard
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities. · FDA Class II
Units
5,953 cartons
Sold at
Nationwide within USA
Description
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
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
Manufacturer(s)
The Harvard Drug Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →