FDA recall D-0426-2015

Product

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

Reason for recall

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-18

Report date

2015-04-01

Termination date

2016-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2015