Product: HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.  NDC Carton: 68084-447-01;  NDC Unit Dose: 68084-447-11
Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Recall initiated: 20240201
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated