FDA WARNING_LETTER - Euphoria Healthcare Pvt Ltd. - September 06, 2019

The FDA and DEA issued a Warning Letter to Euphoria Healthcare Pvt Ltd. on September 6, 2019, for unlawfully selling opioids and other drugs to U.S. consumers over the internet.

The DEA determined that Euphoria Healthcare Pvt Ltd. violates the Ryan Haight Online Pharmacy Consumer Protection Act (RHA) by offering to distribute or dispense controlled substances, including opioids, and advertising their sale without a modified DEA registration. The FDA found that the company introduces misbranded and unapproved new drugs into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, Euphoria Healthcare Pvt Ltd. offers "Aspadol Tab" (tapentadol 100 mg), an unapproved new drug in the U.S., which is also misbranded because it lacks adequate directions for layperson use and is a prescription drug requiring professional supervision. FDA-approved tapentadol carries a black box warning due to risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

The letter demands immediate cessation of violative drug sales and corrective action. Euphoria Healthcare Pvt Ltd. must notify DEA and FDA within 15 working days of steps taken to address violations and prevent recurrence. Failure to comply may result in legal action, including seizure, injunction, or temporary restraining orders, and potential contact with domain name