Named company: Herbsens Botanicals
The claims on your website establish that your kratom products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a)…
Named company: General Nutrition Inc
The firm was notified by a customer that the bottle contains green and white capsules instead of the usual white round tablets. They contacted their manufacturer to investigate the issue and the manufacture…
Named company: NuEra Nutraceutical Inc
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: NuEra Nutraceutical Inc Date Published : 06/21/2022 12031 No. 5 Rd ,…
Named company: Premier Research Labs LLC
Product spoiling over time; spoilage visible beneath lid/closure upon opening.
Named company: New Sun Inc.
The Agency is particularly concerned that you market one of your unapproved new drug products as safe for children. For example, children may be at greater risk for adverse reactions associated with certain…
Named company: PLANTAS MEDICINALES DE MEXICO
"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: PLANTAS…
Named company: Abbott Laboratories
The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
Named company: Plantacea, LLC dba Kahm
The claims on your website and social media websites establish that your products “CBD Hemp Pellets” and “K9 Soft Chews,” which you promote as products containing CBD for use in animals, are unapproved new…
Named company: Golden Lab LLC
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). Unapproved New Drugs and…
Named company: Ayuryoga, Inc.
The claims on your website and social media websites establish that your Kottakkal ayurvedic products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and…
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