PlainRecalls
FDA Drug Moderate Class II Terminated

5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Reported: October 3, 2012 Initiated: September 21, 2012 #D-1686-2012

Product Description

5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

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
753,941 containers
Distribution
Nationwide and Puerto Rico
Location
Round Lake, IL

Frequently Asked Questions

What product was recalled?
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Recalled by Baxter Healthcare Corp.. Units affected: 753,941 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-1686-2012.