FDA recall D-608-2013

Product

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

Reason for recall

Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-06-06

Report date

2013-06-26

Termination date

2015-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-608-2013