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Recall Observatory FDA recall evidence

Food product

Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from settling around the heart, lessens the desire for drugs, cigarettes, alcohol by clearing the body and blood of poison viruses & toxins etc. Relieves fatigue gives stamina and endurance enabling one to do heavy work without getting tired. The tea also relieves depression, headaches, diarrhea, and dysentery. It's used as antibiotic and antidote***Always have Sundial Bissy and Sundial Ethiopian mitmita (Cayenne pepper) for all medical emergencies***"

F-1446-2020

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-1446-2020

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