Drug 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
D-1664-2012
Product summary
- Event
- Event 62756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14380 Bottles
- Official record key
drug-enforcement:D-1664-2012
Official wording
Reason: Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Code information: Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Microbial contamination
Microbial Contamination