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 # 3A404012V
    • Exp. 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 13, 2017 · Data as of Sep 19, 6:22 PM UTC

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