FDAFDA · Food and drugs·Recall number D-1507-2020
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Published August 26, 2020 · Recall initiated: August 10, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ELITEK
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Distributor
- Nationwide in the US
- Lot
- Lot #: A9306, Exp 2/28/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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