FDA recall D-619-2013

Product

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, 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-619-2013