FDA-Drug2024-02-14Class III
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
Amerisource Health Services LLC
Hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Sold states
Nationwide in the USA
Affected count
2,850 cartons
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2024Don't want to check this manually?
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