D-0039-2024 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 11, 2023
- Initiation Date
- September 1, 2023
- Termination Date
- July 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,344 cartons
Product Description
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: 1007002, Exp 12/31/2023