Drug product
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
D-0840-2016
Product summary
- Event
- Event 73671
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2928 bottles
- Official record key
drug-enforcement:D-0840-2016
Official wording
Reason: Failed Dissolution Specifications; three month stability time point.
Code information: Lot: 2005441, 01/2017, Code: 0378-3978-93
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications