Teva North America recalls Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: T…

Recall date

December 21, 2015

Source

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

Recall number

D-0732-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications: low test results at the 18 month time-point

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

What was recalled

Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89