Drug recall D-013-2014

Class II Terminated reported Nov 27, 2013

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.

Lots and codes

29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
681,400 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
September 24, 2013
Terminated
October 6, 2014

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