Drug product
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
D-0097-2019
Product summary
- Event
- Event 80790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,785 bottles
- Official record key
drug-enforcement:D-0097-2019
Official wording
Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information: Lot #: a) 1291192A, Exp 01/2020; b) 1291193A, Exp 01/2020
Distribution pattern: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Derived failure modes
-
Unknown
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.