D-851-2013 Class II Terminated
FDA drug recall D-851-2013 was initiated by Hospira, Inc. on May 20, 2013 and is designated Class II. 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 The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 340,600 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 14, 2013
- Initiation Date
- May 20, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340,600 vials
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot 25394DK, exp. 01/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-851-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026