FDA Drug recall 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
- FDA Drug
- Class II
- ongoing
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75 by Sanofi Aventis U S, citing failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1507-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-10 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sanofi Aventis U S |
| Distribution | US |
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
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Identifiers
| ndc | 0024-5150-10 |
|---|---|
| ndc | 0024-5154-11 |
| ndc | 0024-5152-11 |
| ndc | 0024-5151-75 |
| ndc | 0024-5155-74 |
| ndc | 0024-5153-74 |
| code_info | Lot #: A9306, Exp 2/28/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1507-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.