US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Aug 10, 2020 (6 years ago)

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

What was recalled

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

Recalling firm
Sanofi-Aventis U.S. LLC
NDC code
0024-5151-75
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1507-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.