FDA recall D-0429-2015

Product

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

Reason for recall

Lack of Assurance of Sterility; increased complaints received for leaks

Distribution

Nationwide and Singapore

Key facts

Status

Terminated

Initiation date

2015-03-23

Report date

2015-04-08

Termination date

2016-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2015