FDA recall D-0840-2016
Mylan Pharmaceuticals Inc. · Class II · drug
Product
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Reason for recall
Failed Dissolution Specifications; three month stability time point.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-02-12
- Report date
- 2016-05-18
- Termination date
- 2016-10-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Morgantown, WV, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0840-2016