FDA WARNING_LETTER - Dream Pharmacy 24/7 Enterprises Limited 2018 - July 13, 2021

The FDA issued a Warning Letter to Dream Pharmacy 24/7 Enterprises Ltd. 2018 on July 1, 2021, after reviewing their websites, www.premier-dream.com and www.eirmed360.com. The agency found that Dream Pharmacy 24/7 is introducing misbranded and unapproved new drugs into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act. Specifically, the firm was observed selling unapproved and misbranded opioid drug products (e.g., Tramadol, Oxymorphone), benzodiazepine drug products (e.g., Clonazepam), and drugs claiming to treat COVID-19 and other serious conditions (e.g., Hydroxychloroquine). These products lack FDA approval, making them unapproved new drugs. Furthermore, their labeling fails to provide adequate directions for use, misbranding them under section 502(f)(1). The company also misbrands prescription drugs by dispensing them without a valid prescription, violating section 503(b)(1) and 301(k). The FDA highlighted the severe public health risks, especially concerning opioids and benzodiazepines. Dream Pharmacy 24/7 must cease selling all violative drugs and respond within 15 working days detailing corrective actions and prevention measures, or face legal action like seizure or injunction.