FDA recall D-812-2013

Product

ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.

Reason for recall

Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-07-18

Report date

2013-07-31

Termination date

2014-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-812-2013