FDA recall D-1687-2012

Product

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).

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-1687-2012