FDA recall D-1664-2012

Capco Custom Packaging Inc · Class II · 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

Reason for recall

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

Distribution

Nationwide and Canada

Key facts

Status
Terminated
Initiation date
2012-07-27
Report date
2012-09-05
Termination date
2013-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Fe Springs, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1664-2012