Drug recall D-1507-2020

Class II Ongoing reported Aug 26, 2020

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

Reason for recall

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

Lots and codes

Lot #: A9306, Exp 2/28/2022

Recall details

Recalling firm
Sanofi-Aventis U.S. LLC, Bridgewater, NJ
Quantity
7451 vials
Distribution
Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
August 10, 2020

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