FDA recall D-0823-2018

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.

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.

Key facts

Status

Terminated

Initiation date

2018-05-01

Report date

2018-05-30

Termination date

2021-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0823-2018