Why it was recalled
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
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***"
Lot numbers, UPCs & expiration codes
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Where it was sold
NY
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1446-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2020
- FDA report date
- Sep 9, 2020
- Quantity
- Unknown
- Recall type
- FDA Mandated
- Recalling firm
- Sundial Herbal Products
Original FDA data
Every field from FDA enforcement report F-1446-2020, exactly as published.
Show all FDA fields
- City
- Bronx
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85882
- Address
- 3609 Boston Rd
- Code information
- Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
- Postal code
- 10466-5810
- Report date
- Sep 9, 2020
- Product type
- Food
- Recall number
- F-1446-2020
- Classification
- Class II
- Recalling firm
- Sundial Herbal Products
- Product quantity
- Unknown
- Termination date
- Oct 26, 2022
- Reason for recall
- Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
- Voluntary / mandated
- FDA Mandated
- 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***"
- Distribution pattern
- NY
- Recall initiation date
- Jun 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2020