D-0653-2022 Class II Terminated
FDA drug recall D-0653-2022 was initiated by The Harvard Drug Group on February 24, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities. The recall status is terminated (terminated July 16, 2023). Affected quantity: 5,953 cartons.
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