RecallFDA · Jun 17, 2021
Named company: SAN Corporation
FDA inspection found New Dietary Ingredient, Hordenine, in the supplement product.
Warning letterFDA · Jun 7, 2021
Named company: Flora Inc
J Clin Psychopharmacol. 2009 Aug;29(4):378-82. 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).…
RecallFDA · Jun 4, 2021
Named company: Bomunity Ltd Co
Potential to be contaminated with bacteria
Warning letterFDA · May 27, 2021
Named company: Fresh Nutrition Inc
Based on our review, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs The claims on your website and Amazon product pages…
Warning letterFDA · May 26, 2021
Named company: Omega Wonders LLC.
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 Cardia 7 Heart Health OMEGA 7 and Advanced…
Warning letterFDA · May 26, 2021
Named company: JLM Nutritionals, Inc. dba JLM Nutrition, Super Naturals Health
Reduces risk of Stroke Ulcerative Colitis relief Kidney stone reduction Anti-cardiovascular disease Hypertension reduction (High Blood Pressure) Anti-diabetes via steadying of insulin-glucose balance” • “When…
RecallFDA · May 25, 2021
Named company: Lopez Gonzalez Santana Corporation
CGMP Deviations: Presence of damaged tablets
RecallFDA · May 25, 2021
Named company: Lopez Gonzalez Santana Corporation
CGMP Deviations: Presence of damaged tablets
RecallFDA · May 24, 2021
Named company: IHERB LLC
Informed by contract manufacturer that the MCT ingredient used in their product was under recall due to undeclared milk.
Warning letterFDA · May 20, 2021
Named company: Fertility Nutraceuticals LLC
A 2007 study demonstrated that DHEA decreases the miscarriage rate of women” Article titled: “ 4 Important Fertility Questions Answered ”: • “Fertinatal Fertility DHEA has been show in multiple studies to . .…