Sundial Herbal Products product recalled over labeling errors

Recall date

June 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sundial Herbal Products recalls "SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to h…

Recall number

F-1489-2020

FDA classification

Class II

Brand / firm

Sundial Herbal Products

Sold / distributed

NY

Why it was recalled

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

"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