Kleenhanz, LLC

Warning LetterOpen

Mr. Lance FitzSimon Kleenhanz, LLC 1102 E Sonterra Blvd Ste 100 San Antonio , TX 78258-4063 United States lance@kleenhanz.comIssued Apr 19, 2022Center for Drug Evaluation and Research | CDER

View Letter

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

Letter Details

Firm: Kleenhanz, LLC
Location: Mr. Lance FitzSimon Kleenhanz, LLC 1102 E Sonterra Blvd Ste 100 San Antonio , TX 78258-4063 United States lance@kleenhanz.com
FEI Number: N/A
Country: United States
Issue Date: April 19, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Kleenhanz, LLC was cited for selling unapproved drug products (Kleenhanz® Towelettes topical antiseptic) that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, in violation of section 505(a) of the FD&C Act. The products were also deemed misbranded under section 502(ee) of the FD&C Act and were marketed to consumers through the company's website and social media platforms with links to retail sellers including Amazon.com. The FDA found that the introduction and delivery of these products into interstate commerce violated sections 301(a) and (d) of the FD&C Act, particularly concerning given the ongoing public health emergency related to COVID-19 at the time.