FDA recall D-013-2014

Hospira Inc. · Class II · drug

Product

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03

Reason for recall

Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2013-09-24
Report date
2013-11-27
Termination date
2014-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-013-2014