Vi-Jon Alcohol-Free Antiseptic Mouth Rinse Recalled for Microbial Contamination
Vi-Jon, Inc. is recalling 18,408 bottles of Alcohol Free Antiseptic Mouth Rinse because a stability sample was found to be contaminated with Burkholderia contaminans.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of the product is not likely to cause adverse health consequences. The hazard is microbial contamination in a non-sterile product without reported illnesses.
Plain-English summary
Vi-Jon, Inc. is recalling 18,408 bottles of Alcohol Free Antiseptic (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle. The product is distributed by The Kroger Co. in Cincinnati, OH, and carries the UPC 0 41260 33606 5. The specific lot number is 0185828, with an expiration date of 12/14.
The recall was initiated because a stability sample of the product was found to be contaminated with Burkholderia contaminans. This is a non-sterile product recall involving microbial contamination.
The affected product was distributed nationwide. Consumers should check their inventory for the specific lot number and expiration date listed above. If they possess the affected product, they should stop using it and follow instructions from the recalling firm or retailer regarding disposal or return.
The recalled product
- 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.
- Manufacturer
- Vi-Jon, Inc.
- Category
- Drug — Oral Care
- Hazard
- Affected units
- 18,408
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0185828
- Exp 12/14
Distribution
Distributed nationwide across the United States.
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