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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

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.
Recall Number D-812-2013
Classification Class III
Code Info Lot #: 0185828, Exp 12/14
Product Distributed Qty 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.

Event Detail

Event Id 65761
Product Type Drugs
Status Ongoing
Recalling Firm Vi-Jon, Inc.
City Smyrna
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide