On July 7, 2020, the FDA issued a warning letter to Ionogen, LLC for selling products with unsupported claims that they can treat coronavirus (COVID-19).
The agency emphasized that there are currently no approved treatments for the virus and has previously stated: "There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19).
The product Ionopure Skin & Hands was promoted as a "safe and effective alternative to traditional hand sanitizers" with statements such as "The World Health Organization has stated that any chlorine-based solution of at least 500 ppm FAC will kill COVID-19. Ionopure Skin & Hands... meet[s] this standard."
The FDA instructed the companies to send an email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps they have taken to correct these violations.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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