Recalls / Class II
Class IID-851-2013
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.
- Brand name
- Ondansetron
- Generic name
- Ondansetron
- Active ingredient
- Ondansetron Hydrochloride
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-4755, 0409-4759
- FDA application
- ANDA077548
- Affected lot / code info
- Lot 25394DK, exp. 01/2015
Why it was recalled
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
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 340,600 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-20
- FDA classified
- 2013-08-07
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-851-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.