Drug Recall: 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
Amerisource Health Services LLC · February 1, 2024
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.
Product Description
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
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
2,850 cartons
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0320-2024
Status: ongoing
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