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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

Genzyme Corporation: Clolar (clofarabine) Injection Recalled for Incorrect or Missing Package Insert

Agency Publication Date: November 10, 2017
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Summary

Genzyme Corporation is recalling 9,343 vials of Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection due to an issue where the package insert is either incorrect or missing entirely. Clolar is a prescription medication used for intravenous injection, and having accurate labeling is critical for safe administration. If you or a family member are using this medication, it is important to verify the lot numbers against those affected by this recall. You should contact your healthcare provider or pharmacist immediately to discuss your treatment and ensure you have the correct prescribing information.

Risk

A missing or incorrect package insert means that healthcare providers or patients may not have access to essential safety information, dosage instructions, or potential side effects, which could lead to improper use of the medication.

What You Should Do

  1. Locate your Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection vials and check the packaging for the following Lot numbers and Expiration dates: Lot K5006Y01 (Exp. 08/31/18), Lot K5006Y03 (Exp. 08/31/18), or Lot K6001Y01 (Exp. 03/31/19).
  2. Check the National Drug Code (NDC) printed on the vial or carton to see if it matches NDC 0024-5860-01.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is part of this recall.
  4. Return any unused product to the pharmacy or place of purchase for a refund.
  5. Contact Genzyme Corporation directly for further instructions regarding this recall.
  6. 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

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Clolar (clofarabine) Injection (20 mg/20 mL)
Model:
NDC 0024-5860-01
Lot Numbers:
K5006Y01 (Exp. 08/31/18)
K5006Y03 (Exp. 08/31/18)
K6001Y01 (Exp. 03/31/19)
Date Ranges: 08/31/18, 03/31/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78286
Status: Resolved
Manufacturer: Genzyme Corporation
Sold By: hospitals; specialty pharmacies
Manufactured In: Netherlands, United States
Units Affected: 9,343 single dose 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 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.