FDA recall D-183-2013

Product

0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,

Reason for recall

Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-08

Report date

2013-03-13

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-183-2013