FDA recall D-1689-2012

Product

0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; 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-1689-2012