HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distrib...
FDA Recall #D-0039-2024 — Class III — September 1, 2023
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.
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
3,344 cartons
Distribution
Nationwide in the USA
Code Information
Lot#: 1007002, Exp 12/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated