Drug 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
D-0039-2024
Product summary
- Event
- Event 93089
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,344 cartons
- Official record key
drug-enforcement:D-0039-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Code information: Lot#: 1007002, Exp 12/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification