Drug 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
D-1507-2020
Product summary
- Event
- Event 86219
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7451 vials
- Official record key
drug-enforcement:D-1507-2020
Official wording
Reason: Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Code information: Lot #: A9306, Exp 2/28/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of Specification