Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Clofarabine injection Recalled by Sanofi-Aventis U.S. LLC Due to Labeling: Incorrect or Missing Package Insert: authorized generic...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sanofi-Aventis U.S. LLC directly.
Affected Products
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.
Quantity: 422 vials
Why Was This Recalled?
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report