FDAFDA · Food and drugs·Recall number D-0732-2016
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
Published March 9, 2016 · Recall initiated: December 21, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: low test results at the 18 month time-point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CAPECITABINE
- Manufacturer
- Teva North America
- Distributor
- Nationwide
- Lot
- Lot # 3A404012V, Exp. 4/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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