Amerisource Health Services LLC recalls HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Healt
Recalled October 11, 2023 · FDA recall D-0039-2024 · Amerisource Health Services
Hazard
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. · FDA Class III
Units
3,344 cartons
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Product
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
Manufacturer(s)
Amerisource Health Services LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →