Class II
Ongoing
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
- Company
- Sanofi-Aventis U.S. Llc
- Recall Initiated
- August 10, 2020
- Posted
- August 26, 2020
- Recall Number
- D-1507-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7451 vials
- Firm Location
- Bridgewater, NJ, United States
Reason for Recall
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Distribution
Nationwide in the US
Lot / Code Info
Lot #: A9306, Exp 2/28/2022
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