FDA-Drug2016-03-09Class II

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

Teva North America
Hazard

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

Sold states
Nationwide
Affected count
1,895 bottles
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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 notice

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

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