mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 31318659B, Exp 02/17
- 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 Impurities/Degradation Specifications: High out of specification results for Impurity D.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Product Codes/Lot Numbers:
Lot # 31318659B, Exp 02/17
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1451-2016
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