FDA recall D-0732-2016

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 for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-21

Report date

2016-03-09

Termination date

2017-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0732-2016