FDA recall D-614-2013

Hospira Inc. · Class II · drug

Product

5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Distribution

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

Key facts

Status
Terminated
Initiation date
2012-05-04
Report date
2013-07-03
Termination date
2015-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-614-2013