FDA WARNING_LETTER - HA Stores, Ltd

The FDA issued a Warning Letter to HA Stores, Ltd. for offering unapproved new drugs and misbranded drugs for sale on multiple websites, including healthymedz.com.ru and rx-easymeds.com. The products violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, "Roxicontin" (Roxicodone) is marketed as a narcotic pain reliever without FDA approval, despite FDA-approved Roxicodone bearing a black box warning for serious risks like addiction and respiratory depression. "Slimall (Meridia)," marketed for obesity, is also unapproved; Meridia was voluntarily withdrawn from the U.S. market in 2010 due to increased risks of heart attack and stroke.

These products are considered misbranded under section 502(f)(1) because they lack adequate directions for safe use by a layperson, as they are prescription drugs. The FDA emphasizes the particular concern regarding Roxicodone due to the opioid abuse epidemic.

HA Stores, Ltd. must immediately cease marketing these violative drug products. Failure to correct these violations may result in regulatory actions such as seizure or injunction. A written response detailing corrective actions is required within 10 working days.