FDA WARNING_LETTER - MediPK

The FDA issued a Warning Letter to MediPK after reviewing its websites, determining they offer unapproved new drugs and misbranded drugs for sale to U.S. consumers, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act. Specifically, products like "Tonoflex SR" (tramadol) and "Brufen Plus+" (codeine/ibuprofen) are considered unapproved new drugs under sections 201(g) and 201(p) because they lack FDA approval under section 505(a) and are not generally recognized as safe and effective for their labeled uses. The introduction of these unapproved drugs into interstate commerce violates sections 301(d) and 505(a). Furthermore, these products are misbranded under section 502(f)(1) because their labeling fails to bear adequate directions for use, as they are prescription drugs not amenable to self-diagnosis and treatment by a layperson (21 CFR 201.5). The introduction of these misbranded drugs into interstate commerce violates section 301(a). The FDA emphasized the significant risk to consumers, particularly given the opioid epidemic, as unapproved drugs lack safety assurance and may be counterfeit or contain incorrect ingredients. MediPK must immediately cease marketing these violative products and respond within 10 working days detailing corrective actions to prevent recurrence, or face potential regulatory actions like seizure or injunction.