Home / Sundial Herbal Products / F-1489-2020
Class II
Sundial Herbal Products
Recall #F-1489-2020 · Initiated 2020-06-30
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
NY
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
2022-10-26
Recalling firm
Sundial Herbal Products
3609 Boston Rd
Bronx, NY 10466-5810
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.
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