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
Reason for recall: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: 20180806
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated