Docetaxel injection concentrate — Class II drug recall D-0804-2018
Terminated recall by Sanofi-Aventis U.S. LLC, reported 2018-05-09, distributed nationwide. Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distribute
| Recall number | D-0804-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2018-04-27 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2021-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 19,580 vials |
| Reason classes | potency |
| NDC | 00955-1020, 00955-1020-01, 00955-1021, 00955-1021-04, 00955-1022, 00955-1022-08 |
| Lot numbers | 7F307A, 7F307C |
| Expiration dates | 2019-01 |
Product
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Reason for recall
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
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-0804-2018. 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.