FDA Drug Class II — Moderate

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.

Hazard

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

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Products

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.
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot #: 3092310, Exp. 03/2019

Units Affected

1,152 blister cards of 100 capsules each

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