Drug Enforcement D-812-2013

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

Status

Terminated

Classification

Class III

Report Date

July 31, 2013

Termination Date

June 17, 2014

Product Information

Product description
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.
Product quantity
18,408 bottles
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Vi-Jon, Inc.
Address
1 Swan Dr., N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-812-2013
Event ID
65761
Recall initiation date
July 18, 2013
Center classification date
July 22, 2013
Code info
Lot #: 0185828, Exp 12/14
More code info
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