Warning letterFDA · Sep 7, 2021
Named company: Live Good 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 “Berry Gen Sugar Control” product fails to…
Warning letterFDA · Sep 7, 2021
Named company: Metamune 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, DiabetesSupport, fails to bear adequate…
Warning letterFDA · Sep 7, 2021
Named company: Phytag Labs
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 GLUCOTYPE2 product fails to bear adequate…
RecallFDA · Sep 2, 2021
Named company: Monarch PCM, LLC
Stability is out of spec at 81% for 3 month time period.
Warning letterFDA · Aug 31, 2021
Named company: New York Nutrition Company / American Metabolix
In addition, as explained further below, the Exile Euphoric Weight Loss, Exile Super Shock, Havok Hardcore, and Keto Pump in Watermelon and Grape Flavors products are adulterated under section 402(a)(2)(C)(i)…
Warning letterFDA · Aug 26, 2021
Named company: Fibromyalgia Treatment Group - FTG, LLC
After working my way through 5 doctors at a major hospital in Reno, I was diagnosed with fibromyalgia. Examples of such testimonials include: “I was having nerve pain at night I started taking neuro boost…
RecallFDA · Aug 18, 2021
Named company: Albanese Confectionery Group, Inc.
Product contains comingled Olly Sleep dietary supplement which may cause drowsiness
Import alertFDA · Aug 13, 2021
Named company: SIRIO PHARMA CO., LTD.
"Detention Without Physical Examination of All Dried Shark Fins, Dried Fish Maws and Dried Shark Cartilage Powder from Shark Fins Due to Filth". Firm/address: SIRIO PHARMA CO., LTD. Date Published : 08/13/2021…
Warning letterFDA · Aug 11, 2021
Named company: Je Dois Lavoir LLC
Therefore, this product is an unapproved new drug 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), and a misbranded drug…
Warning letterFDA · Aug 6, 2021
Named company: Blue Poppy Enterprises 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 Modified Perilla & Mentha, Empowered…