Drug product
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
D-0825-2018
Product summary
- Event
- Event 79955
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,650 bottles
- Official record key
drug-enforcement:D-0825-2018
Official wording
Reason: CGMP Deviations
Code information: NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, 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