Recalls / Class II
Class IID-1507-2020
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
- Brand name
- Elitek
- Generic name
- Rasburicase
- NDCs
- 0024-5150, 0024-5151
- FDA application
- BLA103946
- Affected lot / code info
- Lot #: A9306, Exp 2/28/2022
Why it was recalled
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 7451 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2020-08-10
- FDA classified
- 2020-08-17
- Posted by FDA
- 2020-08-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1507-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.