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

Recall Number: D-0653-2022

Firm: The Harvard Drug Group

Classification: Class II

Status: Terminated

Report Date: 20220323

Initiation Date: 20220224

Termination Date: 20230716

Reason for Recall

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

Product Description

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