Named company: The Health Management Group Inc.
Based on our review, we have determined that your “AM/PM Weight Control Patches” is an unapproved new drug in violation of sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Based on our…
Named company: Nutreglo Products, LLC.
The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina…
Named company: Nutreglo Products, LLC.
The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina…
Named company: Revibe, Inc.
FDA has determined that these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).…
Named company: Kratom Spot
FDA has determined that these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).…
Named company: Front Range Kratom
FDA has determined that these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).…
Named company: Nature's Only Choice
The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug.
Named company: Baker's Best Health Products, 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 Eterni-D and Apple Cider Vinegar+ products…
Named company: Eden's Ethnos, LLC
FDA and state samples found Salmonella in Kratom products that traced back to Eden Ethnos LLC.
Named company: Viable Solutions, LLC
Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali Kratom products are being recalled because they have the potential to be contaminated with Salmonella
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