Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistMexHealth LLC was warned for distributing an unapproved new drug called "Ossos-Sans" through its website in violation of the Federal Food, Drug, and Cosmetic Act. FDA laboratory analysis revealed the product contained undeclared active pharmaceutical ingredients—diclofenac (an NSAID) and methocarbamol (a muscle relaxant)—which posed serious health risks including cardiovascular events, gastrointestinal bleeding, sedation, and impaired motor function, while the product was deceptively labeled as a dietary supplement. The company violated sections 505(a) and 301(d) of the FD&C Act by introducing an unapproved new drug into interstate commerce and section 502 by misbranding the product, following FDA inspections of the company's website in April and July 2024.