FDA recall D-851-2013

Hospira, Inc. · Class II · 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.

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

Nationwide

Key facts

Status
Terminated
Initiation date
2013-05-20
Report date
2013-08-14
Termination date
2014-10-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-851-2013