FDA recall D-1096-2014

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09

Reason for recall

Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-02-11
Report date: 2014-03-12
Termination date: 2015-03-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1096-2014