Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted April 27, 2022
FDA Warns Manufacturer of Topical Antiseptic Products for COVID Claims
On April 19th, 2022, the FDA issued a warning letter to Kleenhanz, LLC following a review of the company’s website and social media which found statements about the company’s Kleenhanz Towelettes topical antiseptic products to be drug claims.
For example, the company promoted its product on Twitter with statements such as, “Protect yourself against Coronavirus: Think of your hands as your number one problem. Get Kleenhanz for you and your family!” and “Coronavirus is very real and not going away anytime soon! Get #Kleenhanz now on Amazon to protect your family!!”
The FDA warned that these statements are misleading by promoting products as safe and/or effective for the treatment or prevention of COVID-19. Kleenhanz Towelettes products were also promoted to treat and prevent other pathogens, including but not limited to, “...Human immunodeficiency virus (HIV) type 1… Hepatitis type B & C…Herpes simplex type 1 & 2…Influenza A (H1N1) …MRSA… Staphylococcus aureus…Enterococcus VRE… Neisseria gonorroheae [sic]…Influenza A2… Norwalk… Rotavirus…Candida albicans… E Coli MG1655 type…Chlamydia trachomatis…”
Other violations include using unapproved active ingredients not generally recognized as safe and effective for use, such as benzethonium chloride.
The company must send an email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps it has taken to correct these violations.
Learn more about hand sanitizers in ConsumerLab's article about COVID-19 and disinfection.
For more information, use the link below.
See related recalls and warnings: