FDA-Drug2020-08-26Class II
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Sanofi-Aventis U.S. LLC
Hazard
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Sold states
Nationwide in the US
Affected count
7451 vials
Manufactured in
55 Corporate Dr, N/A, Bridgewater, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1507-2020Don't want to check this manually?
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