Drug product
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
D-0823-2018
Product summary
- Event
- Event 79977
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,152 blister cards of 100 capsules each
- Official record key
drug-enforcement:D-0823-2018
Official wording
Reason: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Code information: Lot #: 3092310, Exp. 03/2019
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
GMP Deviations