Clofarabine injection — Class III drug recall D-0056-2018
Terminated recall by Sanofi-Aventis U.S. LLC, reported 2017-11-08, distributed nationwide. Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect inse
| Recall number | D-0056-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2017-10-13 |
| Classified | 2017-10-30 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2020-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 422 vials |
| Reason classes | labeling |
| NDC | 00955-1746-01 |
| Lot numbers | K5006Y02 |
| Expiration dates | 2018-08-31 |
Product
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
Reason for recall
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
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-0056-2018. 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.