Eco-Dent Mouth Rinse Recalled for Bacterial Contamination
Capco Custom Packaging is recalling Eco-Dent Sparkling Clean Mint mouth rinse due to contamination with Sphingomonas paucimobilis bacteria.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Capco Custom Packaging Inc is recalling 14,380 bottles of Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent. The product is an 8 fl oz (237 mL) alcohol-free bottle distributed nationwide and in Canada.
The recall was initiated because the product was found to be contaminated with Sphingomonas paucimobilis bacteria. This is a non-sterile product recall involving microbial contamination.
Consumers should stop using the product and return it to the place of purchase for a refund. The affected lot numbers are 4052 (Exp 01/15), 4063 (Exp 02/15), and 4150 (Exp 03/15).
The recalled product
- Product
- Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
- Manufacturer
- Capco Custom Packaging Inc
- Category
- Drug — Oral Care
- Hazard
- Affected units
- 14,380
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 (6)
- Lot #: 4052
- Exp 01/15
- 4063
- Exp 02/15
- 4150
- Exp 03/15.
Distribution
Distributed nationwide across the United States.
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