D-1507-2020 Class II Ongoing
FDA drug recall D-1507-2020 was initiated by Sanofi-Aventis U.S. LLC on August 10, 2020 and is designated Class II. Reason for recall: Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing. The recall status is ongoing. Affected quantity: 7451 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2020
- Initiation Date
- August 10, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7451 vials
Product Description
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 Pattern
Nationwide in the US
Code Information
Lot #: A9306, Exp 2/28/2022