Sanofi-Aventis U.S. LLC recalls Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC
Recalled August 26, 2020 · FDA recall D-1507-2020 · Sanofi-Aventis U.S
Hazard
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing. · FDA Class II
Units
7451 vials
Sold at
Nationwide in the US
Description
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Product
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Manufacturer(s)
Sanofi-Aventis U.S. LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →