FDA WARNING_LETTER - www.trinexpharmacy.com - January 09, 2024

On December 14, 2023, the FDA issued a Warning Letter to www.trinexpharmacy.com for illegally selling unapproved and misbranded drugs to U.S. consumers over the internet. The website was found to be introducing unapproved and misbranded opioid drug products, such as "Tramadol 100mg" by Dimedics, and misbranded Schedule II stimulants, including "Adderall 10mg," into interstate commerce.

These actions violate sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA stated that the "Tramadol 100mg" is an unapproved new drug, lacking FDA approval under section 505(a) of the FD&C Act, and is misbranded under section 502(f)(1) because it lacks adequate directions for layperson use and is not exempt from this requirement. Furthermore, both the tramadol and "Adderall 10mg" products are misbranded under section 503(b)(1) and 301(k) as they are prescription drugs offered for sale without requiring a prescription.

The FDA emphasized the significant public health risks associated with the easy availability of opioids and Schedule II stimulants online,