Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elitek (rasburicase) for injection Recalled by Sanofi-Aventis U.S. LLC Due to Failed Stability Specifications: Out of Specification result for...
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
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Quantity: 7451 vials
Why Was This Recalled?
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
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