Drug 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.
D-851-2013
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 65300
- Status
- Terminated
- Classification
- Class II
- Quantity
- 340,600 vials
- Official record key
drug-enforcement:D-851-2013
Official wording
Reason: 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
Code information: Lot 25394DK, exp. 01/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate