F-1446-2020 Class II Terminated

Recalled by Sundial Herbal Products — Bronx, NY

Recall Details

Product Type
Food
Report Date
September 9, 2020
Initiation Date
June 30, 2020
Termination Date
October 26, 2022
Voluntary/Mandated
FDA Mandated
Product Quantity
Unknown

Product Description

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 Pattern

NY

Code Information

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