Medications & Supplements/Prescription Drugs

Sanofi-Aventis U.S. LLC: Clofarabine Injection Recalled for Incorrect Package Insert Information

Agency Publication Date: October 30, 2017

Summary

Sanofi-Aventis U.S. LLC is recalling 422 vials of Clofarabine injection (20 mg/20 mL). This authorized generic product was mistakenly packaged with the incorrect package insert intended for the brand-name version, Clolar. While the medication itself is correct, the provided printed instructions and safety information do not match the specific generic labeling requirements. No injuries or incidents have been reported to date regarding this labeling error.

Risk

Using a medication with the incorrect package insert may lead to confusion regarding specific dosing instructions, storage requirements, or safety warnings unique to the generic product versus the brand name. While the drugs are chemically similar, accurate labeling is critical for ensuring healthcare providers and patients have the correct administration data.

What You Should Do

Check your medication vials for Clofarabine injection (20 mg/20 mL) in 20 mL single-use vials labeled with NDC 0955-1746-01.
Verify the lot number and expiration date on the vial; this recall specifically affects lot number K5006Y02 with an expiration date of 31AUG18.
Contact your healthcare provider or pharmacist immediately to confirm if your medication is affected and to obtain the correct prescribing information.
Return any unused vials from this specific lot to your pharmacy for a refund and to ensure you receive a product with the correct labeling.
Contact Sanofi-Aventis U.S. LLC at 1-800-633-1610 for further instructions regarding the return process or questions about the labeling error.
For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

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

How to: Return the affected product to the place of purchase for a refund and contact the manufacturer for specific labeling concerns.

Affected Products

Product: Clofarabine injection, 20 mg/20 mL (20 mL Single-Use Vial)

Model:

NDC 0955-1746-01

Lot Numbers:

K5006Y02 (Exp 31AUG18)

Date Ranges: 31AUG18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78232

Status: Resolved

Manufacturer: Sanofi-Aventis U.S. LLC

Sold By: pharmacies; hospitals

Manufactured In: The Netherlands, United States

Units Affected: 422 vials

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 · 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.

Summary

Risk

What You Should Do

Check your medication vials for Clofarabine injection (20 mg/20 mL) in 20 mL single-use vials labeled with NDC 0955-1746-01.

Verify the lot number and expiration date on the vial; this recall specifically affects lot number K5006Y02 with an expiration date of 31AUG18.

Contact your healthcare provider or pharmacist immediately to confirm if your medication is affected and to obtain the correct prescribing information.

Return any unused vials from this specific lot to your pharmacy for a refund and to ensure you receive a product with the correct labeling.

Contact Sanofi-Aventis U.S. LLC at 1-800-633-1610 for further instructions regarding the return process or questions about the labeling error.

For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.