PlainRecalls
FDA Drug Moderate Class II Terminated

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

Reported: October 3, 2012 Initiated: September 21, 2012 #D-1687-2012

Product Description

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

Reason for Recall

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
2,976 containers
Distribution
Nationwide and Puerto Rico
Location
Round Lake, IL

Frequently Asked Questions

What product was recalled?
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03. Recalled by Baxter Healthcare Corp.. Units affected: 2,976 containers.
Why was this product recalled?
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Which agency issued this recall?
This recall was issued by the FDA Drug on October 3, 2012. Severity: Moderate. Recall number: D-1687-2012.