FDA recall D-0334-2015

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11

Reason for recall

Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-12-22
Report date
2015-01-14
Termination date
2015-07-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2015