FDA recall D-1507-2020

Sanofi-Aventis U.S. LLC · Class II · drug

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

Reason for recall

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

Distribution

Nationwide in the US

Key facts

Status
Ongoing
Initiation date
2020-08-10
Report date
2020-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1507-2020