报告人
Sundial Herbal Products/Dietary Supplements - recalled due to Misbranding & Unapproved New Drugs
3年前 •source www.fda.gov
Recall notice
United States
Company name: Sundial Herbal ProductsBrand name: Sundial
Product recalled: Herbal Products/Dietary Supplements
Reason of the recall: Misbranding & Unapproved New Drugs
FDA Recall date: July 09, 2020
Recall details: 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 Herb
- Spiced Tea
- Nigerian Moringa Leaf Powder
- Jamaican Turmeric
- Bitter Wood
- Devil Horsewhip
- Mango Leaf
- Red Water Grass
- Sarsaparilla
- Marsh Marigold
- Sea Moss/Irish Moss
- Dog Blood
- Guava Leaf
- Jack in the Bush
- King of the Forest
- ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)
- Ethiopian Traditional Talba (Flaxseed Meal Cereal)
- Fever Grass
- Jamaican Milk Wiss
- Spanish Needle
- Fig Leaf
- Diabetics
- Flax Seed Oil & Honey Blend
- Bitter Kola (Arogbo)
- Jamaican Bissy Powder
- Ghanian Black Spice
- Piss A Bed
- White Pond Lily
- Purple Sage
- Quassia Wood
- Trumpet Leaf
- White Jointa
- White Sage
- Guinea Hen Weed
- Sundial Cassava Meal
- Cocoa Balls
- African Fever Bush
- Mojo Bush
- Blood Leaf
- Wood & Root Tonic
- Koromantee
- Ashanti
- African Manback Tonic
- Pimento
- Mitmitta (Cayenne Pepper)
- Mahogany Bark
- Chaney Root
- Cerasee Bay Leaves, Mango Bark
- Asthma
- Blood Pressure
- Heart
- Worms and Parasites
- Flu-Allergies /HayFever
- Arthritis
- Axum Traditional Ethiopian Honey Beverage
- Black Sage
- Black Wiss
- Cinnamon
- Palo De Brazil
- Broom Weed
- Bread Nut
- Jamaican and Tropical Raw Honey
- Hemp Seed Oil
- Talibah’s Tooth Powder and Ethiopian Coffe
- Blue Vervain
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, 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. For questions or assistance in carrying out the request, please call Sundial (718) 798-3962.
Check the full recall details on www.fda.gov
Source: FDA
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