RecallFDA · Jul 12, 2022
Vicks Children's Botanicals Liquid Daytime 4oz plastic bottle, recall F-1534-2022
Named company: The Procter & Gamble Company
Acidified/Low Acid dietary supplement with no approved process.
Recalls & Safety Records
Warning letterFDA · Jul 12, 2022
NatureLab Corp. MARCS-CMS 625768, July 12, 2022
Named company: NatureLab Corp.
During the inspection, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. We address your responses below, in relation to each of the noted violations.…
Import alertFDA · Jul 11, 2022
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"
Named company: OMEGA NUTRITION
"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: OMEGA…
Warning letterFDA · Jul 5, 2022
Living Foods LLC MARCS-CMS 622648, July 05, 2022
Named company: Living Foods LLC
We have also determined that your firm is marketing the Relax Far Infrared Ray Sauna in the United States without marketing clearance or approval, in violation of the Act. Unapproved New Drugs Your Bion+Plus…
RecallFDA · Jul 3, 2022
Natreve Vegan Protein Powder 10 servings, 13.1oz (371g), UPC 628831120003 18 servings, 1.47lbs/23.53oz (667g), UPC 628831110073, recall F-1428-2022
Named company: ARBORYPHARM FOODS INC.
Undeclared allergen; milk.
Warning letterFDA · Jul 1, 2022
Thirsty Run LLC / US Royal Honey LLC MARCS-CMS 623359, July 01, 2022
Named company: Thirsty Run LLC / US Royal Honey LLC
Based on our review of your websites and laboratory analysis of your products, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Prohibited Act under Section 301(ll)…
Warning letterFDA · Jul 1, 2022
Shopaax.com MARCS-CMS 626291, July 01, 2022
Named company: Shopaax.com
Based on laboratory analysis of your product, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Prohibited Act under Section 301(ll) FDA confirmed through laboratory…
Warning letterFDA · Jul 1, 2022
1am USA Incorporated dba Pleasure Products USA MARCS-CMS 627006, July 01, 2022
Named company: 1am USA Incorporated dba Pleasure Products USA
Based on our review of your website and laboratory analysis of your product, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Prohibited Act under Section 301(ll)…
Warning letterFDA · Jul 1, 2022
MKS Enterprise, LLC MARCS-CMS 624478, July 01, 2022
Named company: MKS Enterprise, LLC
Based on our review of your website and laboratory analysis of your product, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Prohibited Act under Section 301(ll)…
Warning letterFDA · Jun 30, 2022
Kratom Exchange MARCS-CMS 633972, June 30, 2022
Named company: Kratom Exchange
The claims on your website and social media website establish that your 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),…
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