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

Recall Number: D-0822-2018

Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Classification: Class II

Status: Terminated

Report Date: 20180530

Initiation Date: 20180501

Termination Date: 20210310

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

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