FDA recall D-1583-2014

Product

0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03

Reason for recall

Lack of Assurance of Sterility; complaints of mold in the overpouch

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-30

Report date

2014-09-17

Termination date

2016-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1583-2014