Online Pharmacy Warned for Selling Unapproved COVID-19 Products

The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments.

For example, the company marketed its Lopimune and Hivus-LR products as containing the antivirals lopinavir and ritonavir, falsely claiming that the combination “has been central to most treatment plans for COVID-19.”

Another antiviral product, ribavirin, marketed as Ribasure, was also unapproved by the FDA. The website claimed that the drug was recommended “by some experts” for treating the disease based on its efficacy in treating Middle East Respiratory Syndrome (MERS).

 “We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID‐19‐related use for which they have not been approved by FDA,” the agency said.

The agency gave the firm 48 hours to correct the violations or to explain any delay in taking corrective actions.

Read the warning letter here: www.fdanews.com/04-21-20-UnitedpharmaciesmdWL.pdf. — James Miessler