Reported Mar 9, 2016 · Terminated
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by:…
Teva North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva North America · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle
- Manufactured in Czech Republic byTeva Czech Industries sro, Czech Republic
- Manufactured forTeva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
- Lot codes and dates
Lot # 3A404012VExp. 4/2016
- Amount recalled
- 1,895 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: low test results at the 18 month time-point
This product could cause temporary or reversible health problems — stop using it.
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