Warning letterFDA · Jun 29, 2023
Named company: Dr. Smoke, LLC aka Dr. S, LLC
FDA has determined that your Cheetos Crunchy Flamin’ Hot THC Infused Chips and Doritos Nacho Cheese THC Infused Chips are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act…
Warning letterFDA · Jun 29, 2023
Named company: Nikte’s Wholesale, LLC
FDA has determined that your Delta-8 Gushers, Delta-8 THC Lemonade 500mg, Medicated Jolly Rancher Gummies Sour, and Delta-8 THC Hot Cheetos products are adulterated under section 402(a)(2)(C)(i) of the Federal…
Warning letterFDA · Jun 29, 2023
Named company: Exclusive Hemp Farms/Oshipt.com
FDA has determined that your Oreo Stoneo – Medicated 500mg, Cannaa Banana Delta 8 - Rope Candy 600mg - 7 Flavors, Pot Tarts Strawberry 1000mg - Medicated, Tropical Sour Patch - Delta-8 500mg, Trips Ahoy…
Warning letterFDA · Jun 28, 2023
Named company: Eden’s Answers, Inc.
Based on inspectional findings and subsequent review of product labels collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and…
RecallFDA · Jun 22, 2023
Named company: Jost Chemical Co
Zinc Sulfate Monohydrate, USP may contain elevated levels of lead.
Warning letterFDA · Jun 22, 2023
Named company: Suprimo Imports
As described below, these 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) and 331(d). Furthermore,…
Warning letterFDA · Jun 15, 2023
Named company: Healthtex Distributors, Inc.
The inspection revealed serious violations of FDA’s regulation for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title…
Import alertFDA · Jun 8, 2023
Named company: Chakrapani Ayurveda Clinic & Research Center
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: Chakrapani Ayurveda Clinic & Research Center Date Published : 06/08/2023…
Warning letterFDA · Jun 2, 2023
Named company: Hekma Center, LLC
Urinary system diseases such as urine detention, kidney and bladder stones, overactive bladder (OAB), urinary tract infections and prostatitis. … 7. Moreover, it helps to know the glucose levels in the blood…
Warning letterFDA · Jun 1, 2023
Named company: A&Z Pharmaceutical, Inc.
Research suggests calcium can help control high blood pressure, as it has been shown in several clinical trials that indicate increased calcium intake is linked to lower blood pressure and lower risk of…