To be in compliance with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug claims stating the product(s) can diagnose, cure, mitigate, treat or prevent disease. The recalled drug products are misbranded and deemed unapproved drugs based on labeling claims which could result in a delay of appropriate treatment by a healthcare provider. Because these products are unapproved, their safety and efficacy have not been established. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products.
The products included for recall are:
Tenadam HerbFlax Seed Oil & Honey BlendMitmitta (Cayenne Pepper)Spiced TeaBitter Kola (Arogbo)Mahogany BarkNigerian Moringa Leaf PowderJamaican Bissy PowderChaney RootJamaican TurmericGhanian Black SpiceCerasee Bay Leaves, Mango BarkBitter WoodPiss A BedAsthmaDevil HorsewhipWhite Pond LilyBlood PressureMango LeafPurple SageHeartRed Water GrassQuassia WoodWorms and ParasitesSarsaparillaTrumpet LeafFlu-Allergies /HayFeverMarsh MarigoldWhite JointaArthritisSea Moss/Irish MossWhite SageAxum Traditional Ethiopian Honey BeverageDog BloodGuinea Hen WeedBlack SageGuava LeafSundial Cassava MealBlack WissJack in the BushCocoa BallsCinnamonKing of the ForestAfrican Fever BushPalo De BrazilETHIOPIAN ABISH (FENNUGREEK SEED PWD.)Mojo BushBroom WeedEthiopian Traditional Talba (Flaxseed Meal Cereal)Blood LeafBread NutFever GrassWood & Root TonicJamaican and Tropical Raw HoneyJamaican Milk WissKoromanteeHemp Seed OilSpanish NeedleAshantiTalibah’s Tooth Powder and Ethiopian CoffeFig LeafAfrican Manback TonicBlue VervainDiabeticsPimento
All products used as a Sundial Herbs can be identified by the “Sundial” label with brown glass bottles, boxes, Ziploc bags and paper bags with clear viewing windows. This was distributed state or nationwide via the Sundial Herb website (External Link Disclaimerhttp://sundialherbs.com/sundial/External Link Disclaimer)External Link Disclaimer, or any other website or store pick up at 3609 Boston Road, Bronx, New York. Please contact Sundial Herbs to schedule return orders for proper disposal and destruction of the products.
The Sundial Herb company is halting product distribution of all products on their website and in their store location. Sundial Herbs recommends stopping use of these recalled products. No illnesses have been reported to date. However, if consumers have problems that may be linked to Sundial Herbs they should contact a Doctor immediately.
Your immediate action, and response, is required. For questions or assistance in carrying out the request, please call Sundial (718) 798-3962.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Consumers with further questions may contact Sundial Herbal Products via email atsundialherbalproducts@aol.com .
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