🔍 RecallPedia

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

Class I - Dangerous
💊 Drugs Recalled: October 13, 2017 Sanofi-Aventis U.S. Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: K5006Y02, Exp 31AUG18
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

Product Codes/Lot Numbers:

Lot #: K5006Y02, Exp 31AUG18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0056-2018

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