Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- August 6, 2018
- Posted
- October 31, 2018
- Recall Number
- D-0096-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 27,816 bottles
- Firm Location
- North Wales, PA, United States
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
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Lot / Code Info
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
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