Mexicanrxpharm.com – FDA Warning Letter, Oct 8, 2024

On September 30, 2024, the FDA issued a Warning Letter to Mexicanrxpharm.com for unlawfully selling unapproved and misbranded drugs, specifically opioid products, to U.S. consumers via the internet. This violates sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

The FDA observed Mexicanrxpharm.com introducing unapproved new drugs into interstate commerce, citing examples like "Adiolol Tramadol 100mg" and "Tramacet Tramadol, Paracetamol 37.5 mg/325mg." These products are considered new drugs without FDA approval, violating sections 301(d) and 505(a) of the FD&C Act. FDA-approved tramadol, in contrast, is a prescription opioid with a "black box warning" due to severe risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, the drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use by a layperson. As prescription drugs, they require professional supervision and cannot be safely self-administered, thus violating section 301(a).

Mexicanrxpharm.com is required to cease offering these unapproved and misbranded drugs for sale to U.S.