Recall: D-0732-2016

Class II - Potentially Harmful

Class IIClassification

2015-12-21Initiated

TerminatedStatus

Teva North AmericaFirm

Product

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

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.