Recalls / Class II
Class IIF-1488-2020
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
- Type
- Food
- Affected lot / code info
- Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
- Quantity
- Unknown
Why it was recalled
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Recalling firm
- Firm
- Sundial Herbal Products
- Notification channel
- Letter
- Type
- FDA Mandated
- Address
- 3609 Boston Rd, N/A, Bronx, New York 10466-5810
Distribution
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2020-06-30
- FDA classified
- 2020-09-15
- Posted by FDA
- 2020-09-09
- Terminated
- 2022-10-26
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1488-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings.