Drug Enforcement D-1664-2012

Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.

Status

Terminated

Classification

Class II

Report Date

September 5, 2012

Termination Date

March 28, 2013

Product Information

Product description
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
Product quantity
14380 Bottles
Reason for recall
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide and Canada

Location & Firm

Recalling firm
Capco Custom Packaging Inc
Address
10225 Greenleaf Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-1664-2012
Event ID
62756
Recall initiation date
July 27, 2012
Center classification date
August 28, 2012
Code info
Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.
More code info