FDA recall D-1686-2012

Baxter Healthcare Corp. · Class II · drug

Product

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).

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-09-21
Report date: 2012-10-03
Termination date: 2015-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Round Lake, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1686-2012