Drug recall D-023-2014

Class II Terminated reported Dec 11, 2013

Product

Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.

Reason for recall

Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.

Lots and codes

Lot #17368EV Exp 08/13

Recall details

Recalling firm
Hospira, Inc., Lake Forest, IL
Quantity
29,700 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
September 16, 2013
Terminated
October 28, 2014