D-0096-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2018
- Initiation Date
- August 6, 2018
- Termination Date
- February 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,816 bottles
Product Description
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), 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.
Distribution Pattern
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Code Information
Lot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020