Drug product
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
D-0960-2017
Product summary
- Event
- Event 77393
- Status
- Terminated
- Classification
- Class I
- Quantity
- 360 bottles
- Official record key
drug-enforcement:D-0960-2017
Official wording
Reason: Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Code information: Lot: 1160682A, EXP. 06/18
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications