Teva Pharmaceuticals USA recalls Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0
Recalled October 31, 2018 · FDA recall D-0097-2019 · Teva Pharmaceuticals USA
Hazard
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. · FDA Class II
Units
3,785 bottles
Sold at
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Description
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
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
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →