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Sundial Herbal Products

2 recall records in Produce.

2020

2 records

Class IITerminatedRecall F-1446-2020

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.

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Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1448-2020

Product description

Mitmitta (Cayenne Pepper); "Traditional Uses: Prevents heart attacks, and lowers high blood pressure, stops internal bleeding, Heals ulcers and pains there of: Improves circulation, thins blood and keeps it moving***"

Reason for recall

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

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022