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.
Recall initiated: 20200810
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated