RecallFDA · Dec 5, 2022
Named company: THGH Partners, LLC
Incorrect product label causing undeclared milk.
Warning letterFDA · Nov 22, 2022
Named company: Aspire Pharmaceuticals, Inc.
Based on our inspection and our. review of labeling collected during the inspection, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). We address your response below,…
Import alertFDA · Nov 21, 2022
Named company: PT. Angkutan Jasa Aviasi
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM. Firm/address: PT. Angkutan Jasa Aviasi Date Published : 11/21/2022…
Warning letterFDA · Nov 16, 2022
Named company: Naturally Infused LLC
FDA has determined that your CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, D8 THC Infused coffees, and Delta-8 THC Gummies products are adulterated under section 402(a)(2)(C)(i) of the…
Warning letterFDA · Nov 16, 2022
Named company: Evimeria El Aztecano, Inc.
Based on our subsequent review of the product labeling, we have concluded that this product is in violation of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) and the regulations contained…
Warning letterFDA · Nov 16, 2022
Named company: CBD American Shaman, LLC
FDA has determined that your CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, CBD Honey, Doggy Chews (all flavors), Soft…
Warning letterFDA · Nov 16, 2022
Named company: 11-11-11 Brands
FDA has determined that your Mood33 Hemp Infused Herbal Tea products are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because…
Warning letterFDA · Nov 16, 2022
Named company: Infusionz, LLC
FDA has determined that all strengths, varieties, and various flavors of your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products are adulterated under section…
Import alertFDA · Nov 16, 2022
Named company: AL JUFRI, ZEN
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM. Firm/address: AL JUFRI, ZEN Date Published : 11/16/2022 21556…
RecallFDA · Nov 14, 2022
Named company: Mason Vitamins, Inc.
Product is sub-potent for Vitamins A, B12, B5 (Pantothenic acid), C, and E not meeting label claims.