PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 12, 2013 Initiated: April 30, 2013 #D-502-2013

Product Description

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
44,748 bags
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 44,748 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-502-2013.