FDA recall D-0490-2015

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-04-07
Report date: 2015-04-29
Termination date: 2016-11-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2015