Class II
Terminated
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.
- Recall Initiated
- May 1, 2018
- Posted
- May 30, 2018
- Recall Number
- D-0823-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,152 blister cards of 100 capsules each
- Firm Location
- Rockford, IL, United States
Reason for Recall
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: 3092310, Exp. 03/2019
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