FDA recall D-0825-2018
Mylan Pharmaceuticals Inc. · Class II · drug
Product
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Reason for recall
CGMP Deviations
Distribution
Product was distributed throughout the United States, including Puerto Rico.
Key facts
- Status
- Terminated
- Initiation date
- 2018-04-24
- Report date
- 2018-05-30
- Termination date
- 2019-08-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Morgantown, WV, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0825-2018