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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sanofi-Aventis U.S. LLC: Docetaxel Injection Concentrate Recalled for Over-Concentration

Agency Publication Date: May 14, 2018
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Summary

Winthrop U.S. (a business of Sanofi-Aventis U.S. LLC) is recalling approximately 19,580 vials of Docetaxel injection concentrate (20 mg/mL, 1 mL vial). This prescription chemotherapy medication is being recalled because certain vials may be superpotent, containing a higher concentration of the drug than what is listed on the label. Patients using these specific vials from the affected lots may be at risk of receiving an unintended higher dose. Consumers should contact their healthcare provider or pharmacist immediately for guidance and return any unused vials to the pharmacy.

Risk

The drug vials are over-concentrated or 'superpotent,' which means patients may receive a higher dose of chemotherapy than prescribed. This can lead to increased severity of side effects or potentially toxic reactions.

What You Should Do

  1. Check your medication to see if it is Docetaxel injection concentrate, 20 mg/mL, 1 mL vial.
  2. Identify if your product is from Lot 7F307A or Lot 7F307C with an expiration date of 01/2019.
  3. Verify the National Drug Code (NDC) printed on the label is 0955-1020-01.
  4. If you have an affected vial, contact your healthcare provider or pharmacist immediately for clinical guidance.
  5. Return any unused product from these specific lots to the pharmacy or place of purchase for a refund.
  6. Contact the manufacturer, Sanofi-Aventis U.S. LLC, at their Bridgewater, New Jersey office for further instructions regarding this recall.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to pharmacy for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact Sanofi-Aventis U.S. LLC for further instructions.

Affected Products

Product: Docetaxel injection concentrate, 20 mg/mL, 1 mL vial
Model:
NDC 0955-1020-01
Lot Numbers:
7F307A (Exp 01/2019)
7F307C (Exp 01/2019)
Date Ranges: Expiration Date 01/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79964
Status: Resolved
Manufacturer: Sanofi-Aventis U.S. LLC
Sold By: Pharmacies; Hospitals
Manufactured In: United States
Units Affected: 19580 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.