Elitek (rasburicase) for injection, 7.5 mg vial recall — FDA D-1507-2020
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Overview of recall records associated with Sanofi-Aventis U.S. LLC, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
This page summarizes recall records in which the official source identifies Sanofi-Aventis U.S. LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.