FDA-Drug2013-11-27Class II

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

Hospira Inc.
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
681,400 vials
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
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

Official notice

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

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