rxshopmd.com

Warning LetterOpen

rxshopmd.com CyprusIssued Feb 15, 2022Center for Drug Evaluation and Research | CDER

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: rxshopmd.com
Location: rxshopmd.com Cyprus
FEI Number: N/A
Country: Cyprus
Issue Date: February 15, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

rxshopmd.com, operating from Cyprus, unlawfully sold unapproved and misbranded drug products to U.S. consumers via its website, including products claiming to treat, prevent, diagnose, or cure COVID-19 and HIV in violation of sections 505(a) and 502 of the Federal Food, Drug, and Cosmetic Act. The FDA identified these violations during a website review on December 13, 2021, emphasizing heightened enforcement urgency given the ongoing COVID-19 public health emergency declared by HHS and the President. The company's unapproved drugs lacked FDA safety and effectiveness oversight, posing inherent risks to consumers purchasing these products over the internet.