FDADecember 21, 2015drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

teva north americatevateva north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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