Class III
Ongoing
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
This recall is currently active, issued February 14, 2024. It was issued by Amerisource Health Services Llc.
- Company
- Amerisource Health Services Llc
- Recall Initiated
- February 1, 2024
- Posted
- February 14, 2024
- Recall Number
- D-0320-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,850 cartons
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 1012275, Exp 02/28/2025
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