FDA recall D-0822-2018

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class II · 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

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-0822-2018