On April 20, 2011, the U.S. Food and Drug Administration (FDA) sent out a slew of warning letters reprimanding companies who were making potentially false methicillin-resistant Staphylococcus aureus bacteria (MRSA) claims for their over-the-counter products. Four companies in particular claimed that their hand sanitizers were capable of preventing an MRSA infection.
The FDA warning letters were sent to the following firms regarding their respective products in question:
- Tec Laboratories: Staphaseptic First Aid Antiseptic/Pain Relieving Gel
- JD Nelson and Associates: Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant
- Dr. G.H. Tichenor Antiseptic Co.: Dr. Tichenor’s Antiseptic Gel
- Oh So Clean, Inc dba CleanWell Company: CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap
The aforementioned companies claimed their hand sanitizers could prevent MRSA infections. Unfortunately, they lack sufficient evidence that can demonstrate their effectiveness in dealing with MRSA infections.
Labeling and marketing materials for the misleading products also claim that they can prevent infection from other disease-causing agents. In addition, the labeling of some of the firms’ hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus.
The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes. FDA officials claim that these companies display a blatant disregard for the law and public safety. The companies have 15 days to correct the violations cited in the warning letters. Failure to do so may result in legal action including seizure and injunction.
Do I Have A Class Action Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in class action lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one have purchased any of the products included in this recall, you should contact us immediately. You may be entitled to compensation and / or refund by participating in a class action lawsuit and we can help.