ROCKVILLE, Md. The Food and Drug Administration ordered the seizure of $230,000 in hand-sanitizing gel last week, the agency announced Friday.
The hand sanitizer, made by Puerto Rico Beverage and distributed by Lord Pharmaceutical/Bee International Distributors, currently is only available for sale in Puerto Rico. The product, which contains benzalkonium chloride, is not approved for sale in the U.S. market, the FDA stated.
The gel was marketed as a product that could kill 99.99% of viruses, bacteria and fungi. However, its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter antifungal use, making it noncompliant with FDA’s final monograph for OTC topical antifungal drug products.
“The safety and effectiveness of the active ingredient in this product have not been demonstrated to the FDA,” stated Michael Chappell, FDA acting associate commissioner for regulatory affairs. “Thus, this product is an unapproved new drug and violates federal law. … This seizure action helps ensure that no consumers are harmed by this product.”
The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.
Moreover, the product, which is not labeled correctly, is misbranded under the law because its packaging does not list all inactive ingredients, and its label fails to contain the place of business of the manufacturer, packer or distributor.
The FDA inspected the product manufacturing facility between Aug. 19 and Sept. 28, 2009, and found numerous violations of U.S. current Good Manufacturing Practice requirements, including failure to have a Quality Control Unit; failure to maintain a clean and sanitary processing, packing and holding area; failure to conduct appropriate lab tests and many other violations.
Following that inspection, the firm agreed to recall and destroy its products but has failed to follow through on its commitments. This failure on behalf of the company led the government to request a seizure of the products.
On March 3, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.