Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

FDA recall notice · announced August 26, 2020 · Sanofi-aventis U.s

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot #: A9306, Exp 2/28/2022
Quantity: 7451 vials
Status: Ongoing
Products in this recall event:
- Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75 (D-1507-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.