Warning letterFDA · Jan 6, 2021
Named company: Entia Biosciences, Inc
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your Lion's Mane -All Natural Supplement,…
Public notificationFDA · Jan 6, 2021
Named company: Entia Biosciences, Inc
New Drug/Misbranded
Warning letterFDA · Jan 4, 2021
Named company: Coco's Holistic Specialties & Apothecary
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a…
Public notificationFDA · Dec 22, 2020
Named company: Wellness BioSciences Rx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Import alertFDA · Dec 11, 2020
Named company: HERBALART GIDA SAN VE TIC LTD
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT". Firm/address: HERBALART…
Import alertFDA · Dec 8, 2020
Named company: Hanzhong TRG Biotech Co., Ltd
***"DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS CONTAINING GINSENG THAT FAIL TO PROPERLY DECLARE GINSENG"***. Firm/address: Hanzhong TRG Biotech Co., Ltd Date Published : 12/08/2020 Natural Grain Biotech…
Warning letterFDA · Dec 2, 2020
Named company: Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are…
Warning letterFDA · Dec 2, 2020
Named company: Heavenly Natural Products
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are…
RecallFDA · Nov 17, 2020
Named company: Fusion Health and Vitality LLC
The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements
RecallFDA · Nov 6, 2020
Named company: Quantum Inc
Product recalled due to potential contamination of Salmonella.