The Recall Desk
ModerateFDA (Drugs)·D-1664-2012·Announced 2012-09-05

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.

What this means for you

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
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.