Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Recall Number: D-1507-2020
Firm: Sanofi-Aventis U.S. LLC
Classification: Class II
Status: Ongoing
Report Date: 20200826
Initiation Date: 20200810
Termination Date:
Reason for Recall
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Product Description
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75