Sanofi-Aventis U.S. LLC recalls Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC…
- Recall date
- August 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1507-2020
- FDA classification
- Class II
- Brand / firm
- Sanofi-Aventis U.S. LLC
- Sold / distributed
- Nationwide in the US
Why it was recalled
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
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