PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 27, 2013 Initiated: September 24, 2013 #D-013-2014

Product Description

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
681,400 vials
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 681,400 vials.
Why was this product recalled?
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2013. Severity: Moderate. Recall number: D-013-2014.