July 2012 FDA Recall Drug by Capco Custom Packaging Inc
D-1664-2012 - Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.

This Class II drug recall was voluntarily initiated by Capco Custom Packaging Inc on July 27, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products; product was found to be contaminated with sphingomonas paucimobilis bacteria.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1664-2012

Reason for Recall
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Initiated
07-27-2012
Reported
09-05-2012
Quantity
14380 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62756
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Capco Custom Packaging Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.