Drug product
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
D-0822-2018
Product summary
- Event
- Event 79977
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,065 blister cards of 100 capsules each
- Official record key
drug-enforcement:D-0822-2018
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 #: 3090454, Exp. 03/2019
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
GMP Deviations