hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distr...
FDA Recall #D-0653-2022 — Class II — February 24, 2022
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.
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,953 cartons
Distribution
Nationwide within USA
Code Information
Lot #: T03755, T03756, Exp. Date 03/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated