Sundial Herbal Products

Recall #F-1489-2020 · Initiated 2020-06-30

Plain-language summary

by FoodRecallsDB.info

What happened

The FDA has ordered a recall of Sundial Herbal Products' Koromantee Colonic & Intestinal Cleaner because the product makes health claims that are not approved by the FDA, making it an unapproved drug rather than a legal dietary supplement or food product. The company was issued a permanent injunction to stop selling this product.

Who is at risk

Anyone who has purchased or is using this product should be concerned, as unapproved products have not been tested for safety or effectiveness.

What to do

If you have this product, stop using it and do not consume it. Contact Sundial Herbal Products or your retailer about returning the product, or dispose of it safely. If you have experienced any health problems after using this product, contact your healthcare provider or the FDA.

Product

"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.

Quantity affected

Unknown

Distribution

Lot / code info

Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated