Ondansetron Injection — Class II drug recall D-851-2013
Terminated recall by Hospira, Inc., reported 2013-08-14, distributed nationwide. Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot
| Recall number | D-851-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira, Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-05-20 |
| Classified | 2013-08-07 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 340,600 vials |
| Reason classes | specification failure |
| NDC | 00409-4755, 00409-4755-03, 00409-4755-18, 00409-4759, 00409-4759-01 |
| Lot numbers | 25394DK |
| Expiration dates | 2015-01 |
Product
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Reason for recall
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
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-851-2013. 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.