FDA recall D-502-2013

Hospira Inc. · Class II · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-04-30
Report date: 2013-06-12
Termination date: 2014-10-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-502-2013