Sundial Herb Recall

Tuesday, 14 July 2020 18:09

Sundial Herb Recall Featured

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Company Announcement

To all Stores, Vendors and Customers:

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

Flax Seed Oil & Honey Blend

Mitmitta (Cayenne Pepper)

Spiced Tea

Bitter Kola (Arogbo)

Mahogany Bark

Nigerian Moringa Leaf Powder

Jamaican Bissy Powder

Chaney Root

Jamaican Turmeric

Ghanian Black Spice

Cerasee Bay Leaves, Mango Bark

Bitter Wood

Piss A Bed

Asthma

Devil Horsewhip

White Pond Lily

Blood Pressure

Mango Leaf

Purple Sage

Heart

Red Water Grass

Quassia Wood

Worms and Parasites

Sarsaparilla

Trumpet Leaf

Flu-Allergies /HayFever

Marsh Marigold

White Jointa

Arthritis

Sea Moss/Irish Moss

White Sage

Axum Traditional Ethiopian Honey Beverage

Dog Blood

Guinea Hen Weed

Black Sage

Guava Leaf

Sundial Cassava Meal

Black Wiss

Jack in the Bush

Cocoa Balls

Cinnamon

King of the Forest

African Fever Bush

Palo De Brazil

ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)

Mojo Bush

Broom Weed

Ethiopian Traditional Talba (Flaxseed Meal Cereal)

Blood Leaf

Bread Nut

Fever Grass

Wood & Root Tonic

Jamaican and Tropical Raw Honey

Jamaican Milk Wiss

Koromantee

Hemp Seed Oil

Spanish Needle

Ashanti

Talibah’s Tooth Powder and Ethiopian Coffe

Fig Leaf

African Manback Tonic

Blue Vervain

Diabetics

Pimento

 

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.

Last modified on Tuesday, 14 July 2020 18:11
David Deaton

Digital Editor at Oklahoma Welcome

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