Drug recall D-502-2013

Class II Terminated reported Jun 12, 2013

Product

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32

Reason for recall

Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

Lots and codes

Lot 11-309-KL

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
44,748 bags
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
April 30, 2013
Terminated
October 8, 2014

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