Drug product
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
D-0653-2022
Product summary
- Event
- Event 89663
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,953 cartons
- Official record key
drug-enforcement:D-0653-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Code information: Lot #: T03755, T03756, Exp. Date 03/2023
Distribution pattern: Nationwide within USA
Derived failure modes
-
Potency or specification failure
Out of specification