FDA recall D-611-2013

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Distribution

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

Key facts

Status: Terminated
Initiation date: 2012-05-04
Report date: 2013-07-03
Termination date: 2015-07-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-611-2013