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Recall Observatory FDA recall evidence

Food product

"Sundial***Traditional Jamaican***ORGANIC***Original Maroon Recipe***WOOD AND ROOT TONIC***used for centuries in Jamaica as a household remedy, to cleanse the body and the blood of mucus, and toxic waste.***used by the Carib Indians of Central America to Protect them against epidemics***INGREDIENTS: Purified, Filtered & Distilled Water Chaney Root, Sarsparilla Root, Black Wis, Milk Wiss, African Cayenne, Sour Sop Leaf, Mango Leaf, Cloves, Pimento, Cinnamon***" packaged in 16oz bottles

F-1488-2020

June 30, 2020

Class II

Product summary

Firm
Sundial Herbal Products
Event
Event 85882
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
food-enforcement:F-1488-2020

Official wording

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

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

Distribution pattern: NY

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded