Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 7F307A, 7F307C, Exp 01/2019
- 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:
- Sanofi-Aventis U.S. LLC
- Reason for Recall:
- Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Product Codes/Lot Numbers:
Lot #: 7F307A, 7F307C, Exp 01/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0804-2018
Related Recalls
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Sanofi-Aventis U.S.
Lack of Assurance of Sterility: Malformed crimped collar seal
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Sanofi-Aventis U.S.
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
CGMP Deviations: Presence of NDMA impurity detected in product.