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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sanofi-Aventis U.S. LLC: Enoxaparin Sodium Injection Recalled Due to Mislabeling and Dosage Error

Agency Publication Date: January 5, 2018
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Summary

Sanofi-Aventis U.S. LLC is recalling approximately 11,474 cartons of Enoxaparin Sodium (generic Lovenox) injection after a single syringe containing a 150 mg/1.0 mL dose was found packaged in a blister pack incorrectly labeled as the 120 mg/0.8 mL strength. This voluntary recall affects 10-count cartons distributed nationwide under the Winthrop US brand. Consumers should verify their medication strength immediately as using the incorrect dose can lead to serious health complications.

Risk

A labeling error that causes a patient to receive a higher dose of blood thinner than prescribed (150 mg instead of 120 mg) increases the risk of major bleeding events, which can be life-threatening. No specific injuries were reported in the provided data, but the discrepancy between the syringe label and the outer packaging poses a significant safety risk.

What You Should Do

  1. Immediately check your medication packaging and individual syringes for Winthrop US Enoxaparin Sodium, Injection 120 mg/0.8 mL with NDC 0955-1012-10.
  2. Verify if your medication belongs to Lot 7S572 with an expiration date of 04/2019.
  3. Inspect each individual syringe label carefully to ensure the strength printed on the syringe (e.g., 120 mg) matches the strength printed on the blister pack and the outer carton.
  4. If you identify a syringe labeled as 150 mg/1.0 mL inside a 120 mg blister or carton, do not use the medication.
  5. Contact your healthcare provider or pharmacist immediately for guidance on obtaining a correct replacement and to discuss any health concerns.
  6. Return any unused or mislabeled product to the pharmacy where it was purchased for a refund.
  7. Contact Sanofi-Aventis U.S. LLC for further instructions regarding this recall.
  8. For additional questions or to report a problem, 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 and consult healthcare provider.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Enoxaparin Sodium, Injection 120 mg/0.8 mL (10-count cartons)
Model:
NDC 0955-1012-10
Recall #: D-0153-2018
Lot Numbers:
7S572 (Exp. 04/2019)
Date Ranges: Expiration 04/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78637
Status: Resolved
Manufacturer: Sanofi-Aventis U.S. LLC
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 11,474 cartons of 10 syringes per carton
Distributed To: Nationwide

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.