Home / Sundial Herbal Products / F-1485-2020
Class II
Sundial Herbal Products
Recall #F-1485-2020 · Initiated 2020-06-30
Product
"***PALO DE BRAZIL***BRASIL WOOD***great to reduce the sugar in the blood and removes gall stone from the kidneys***INSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty***"
Reason for recall
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Quantity affected
Unknown
Distribution
NY
Lot / code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Voluntary / mandated
FDA Mandated
Initial notification
Letter
Terminated
2022-10-26
Recalling firm
Sundial Herbal Products
3609 Boston Rd
Bronx, NY 10466-5810
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.
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