Terminated Class II

Sundial Herbal Products

Recall F-1446-2020 · Bronx, NY

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***"

Reason for recall

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

Distribution

NY

Quantity affected

Unknown

Recall type

FDA Mandated

Lot / code info

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

Timeline

30 Jun 2020 initiated → 15 Sep 2020 classified → 9 Sep 2020 reported → 26 Oct 2022 terminated

Sourced directly from the FDA’s openFDA enforcement database. This information is for educational purposes only and does not constitute health or legal advice. FoodRecallFinder.com is not affiliated with or endorsed by the U.S. Food and Drug Administration.