PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 14, 2013 Initiated: May 20, 2013 #D-851-2013

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

Details

Recalling Firm
Hospira, Inc.
Units Affected
340,600 vials
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hospira, Inc.. Units affected: 340,600 vials.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Moderate. Recall number: D-851-2013.