FDAFDA · Food and drugs·Recall number F-1489-2020
"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
Published September 9, 2020 · Recall initiated: June 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Sundial Herbal Products
- Distributor
- NY
- Lot
- Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
- Risk classification
- Class II
- Area (FDA)
- food
- Country
- United States
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