Recalls / Class II
Class IIF-1446-2020
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***"
- 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-1446-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings.