Drug product
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
D-0824-2018
Product summary
- Event
- Event 79955
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,679 bottles
- Official record key
drug-enforcement:D-0824-2018
Official wording
Reason: CGMP Deviations
Code information: NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19
Distribution pattern: Product was distributed throughout the United States, including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations