Terminated Class II

Sundial Herbal Products

Recall F-1489-2020 · Bronx, NY

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.

Distribution

NY

Quantity affected

Unknown

Recall type

FDA Mandated

Lot / code info

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

Timeline

30 Jun 2020 initiated → 15 Sep 2020 classified → 9 Sep 2020 reported → 26 Oct 2022 terminated

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