FDA recall D-1240-2015

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

Reason for recall

Lack of assurance of sterility: Potential channel leaks near the threaded vial port.

Distribution

United States

Key facts

Status: Terminated
Initiation date: 2015-07-02
Report date: 2015-07-22
Termination date: 2016-11-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1240-2015