Recalls / Class II
Class IID-0840-2016
Product
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
- Affected lot / code info
- Lot: 2005441, 01/2017, Code: 0378-3978-93
Why it was recalled
Failed Dissolution Specifications; three month stability time point.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 2928 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-02-12
- FDA classified
- 2016-05-06
- Posted by FDA
- 2016-05-18
- Terminated
- 2016-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0840-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.