Elitek — Class II drug recall D-1507-2020
Ongoing recall by Sanofi-Aventis U.S. LLC, reported 2020-08-26, distributed nationwide. Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine s
| Recall number | D-1507-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2020-08-10 |
| Classified | 2020-08-17 |
| Reported by FDA | 2020-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 7,451 vials |
| Reason classes | specification failure |
| NDC | 00024-5150, 00024-5150-10, 00024-5151, 00024-5151-75, 00024-5152-11, 00024-5153-74, 00024-5154-11, 00024-5155-74 |
| Lot numbers | A9306 |
| Expiration dates | 2022-02-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1507-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.