Medicina Mexico – FDA Warning Letter

The FDA issued a Warning Letter to Medicina Mexico on September 19, 2017, for unlawfully selling unapproved new drugs and misbranded drugs to U.S. consumers via websites like americanonlinepharmacy.com. This violates sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act. The company offers unapproved new drugs, such as chloranfenicol (chloramphenicol), an antibiotic, which lacks FDA approval for interstate commerce per section 505(a). Chloramphenicol was previously withdrawn from the U.S. market due to severe safety concerns, including fatal blood disorders, and carries a black box warning. Products are also misbranded: they fail to bear adequate directions for use, as they are prescription drugs unsuitable for self-diagnosis, violating section 502(f)(1). Moreover, prescription drugs like chloramphenicol and Levaquin are sold without a valid prescription, misbranding them under section 503(b)(1) and violating section 301(k), posing significant patient safety risks. Medicina Mexico must immediately cease marketing these violative products. A written response detailing corrective actions and prevention measures is required within 10 working days. Failure to comply may result in regulatory actions like seizure or injunction.