D-1664-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2012
- Initiation Date
- July 27, 2012
- Termination Date
- March 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14380 Bottles
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
Reason for Recall
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Distribution Pattern
Nationwide and Canada
Code Information
Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.