F-1489-2020 Class II Terminated
Recall Details
- Product Type
- Food
- Report Date
- September 9, 2020
- Initiation Date
- June 30, 2020
- Termination Date
- October 26, 2022
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- Unknown
Product Description
"SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels, stomach, intestines, and colonic areas of the body.***" packaged in 16oz glass bottles
Reason for Recall
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Distribution Pattern
NY
Code Information
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.