FDA WARNING_LETTER - Tramadol US - August 16, 2022

The FDA issued a Warning Letter to Tramadol US for unlawfully selling unapproved and misbranded opioid and benzodiazepine drugs to U.S. consumers via the internet, posing significant public health risks, especially given the opioid epidemic and dangers of benzodiazepine nonmedical use. The company introduces unapproved new drugs, such as "Tramadol 100mg" and "Opana ER 15mg," into interstate commerce without prior FDA approval, violating sections 301(d) and 505(a) of the FD&C Act. These drugs are also misbranded under section 502(f)(1) because their labeling lacks adequate directions for use, as they are prescription-only and not safe for layperson self-treatment. Furthermore, Tramadol US offers prescription drugs, including "Yellow Xanax Bars" (alprazolam), for sale without requiring a prescription, which misbrands them under section 503(b)(1) and violates section 301(k) of the FD&C Act. The FDA mandates Tramadol US to immediately cease offering all unapproved and misbranded drugs. The company must respond in writing within 15 working days, detailing corrective actions and prevention measures. Failure to comply may lead to legal actions like seizure and injunction, and products may be detained or refused admission.