D-0653-2022 Class II Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
March 23, 2022
Initiation Date
February 24, 2022
Termination Date
July 16, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,953 cartons

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

Reason for Recall

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

Distribution Pattern

Nationwide within USA

Code Information

Lot #: T03755, T03756, Exp. Date 03/2023