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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 3A404012V, Exp. 4/2016
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teva North America
- Reason for Recall:
- Failed Dissolution Specifications: low test results at the 18 month time-point
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot # 3A404012V, Exp. 4/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0732-2016
Related Recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations