The Harvard Drug Group: Drug Recall

Recall #D-0653-2022 · 02/24/2022

Class II: Risk

Recall Details

Recall Number: D-0653-2022
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 02/24/2022
Location: Livonia, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,953 cartons

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

Distribution Pattern

Nationwide within USA

Other Recalls by The Harvard Drug Group

Class II: Risk 06/16/2023

Packaging defect: blister packaging inadequately sealed.
Class III: Low Risk 04/24/2023

Product mixup: one foreign tablet found in product.
Class II: Risk 02/23/2023

Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II: Risk 02/28/2022

Failed Dissolution Specifications
Class II: Risk 08/06/2021

Failed Dissolution Specifications

View all recalls by The Harvard Drug Group →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.