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…

Recall date

August 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0097-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

Why it was recalled

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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