Reported Aug 26, 2020 · Ongoing
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC…
Sanofi-Aventis U.S. LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi-Aventis U.S. LLC · 55 Corporate Dr · Bridgewater, NJ · 08807-1265
Is this the product you have?
- Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
- Lot codes and dates
Lot #: A9306Exp 2/28/2022
- Amount recalled
- 7451 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
This product could cause temporary or reversible health problems — stop using it.
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