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FDAFDA · Food and drugs·Recall number F-1488-2020

"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

Published September 9, 2020 · Recall initiated: June 30, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

FDA Mandated · Letter

Recall details

Manufacturer
Sundial Herbal Products
Distributor
NY
Lot
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Risk classification
Class II
Area (FDA)
food
Country
United States

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