FDA recall D-176-2013

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

Reason for recall

Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-02-12
Report date
2013-03-06
Termination date
2015-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-176-2013