Drug product
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
D-0320-2024
Product summary
- Event
- Event 93936
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2,850 cartons
- Official record key
drug-enforcement:D-0320-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Code information: Lot #: 1012275, Exp 02/28/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification