FDA MedWatch: Hand Sanitizers: FDA Updates On Recalls

 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: Hand Sanitizers: FDA Updates on Recalls Due to Dangerous, Potential Presence of Methanol (Wood Alcohol) AUDIENCE: Consumer, Health Professional ISSUE: FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. The agency is aware of people ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death. Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA maintains a list of FDA-tested and recalled hand sanitizers on the agency’s website, which will be continually updated as dangerous products are discovered. FDA’s investigation of methanol in certain hand sanitizers is ongoing. Do not use any products on this list of hand sanitizers with potential methanol contamination, and continue checking this list often as it is being updated daily. This list outlines the information on hand sanitizer labels for consumers to use to identify a product that has been tested by FDA and found to contain methanol. FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers. The agency will provide additional information as it becomes available. Recent recalls include: Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020 Incredible Products Sa De Cv Issues Voluntary Nationwide Recall of Gelbac T Antibacterial Handgel BACKGROUND: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

RECOMMENDATION: FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially: After going to the bathroom Before eating After coughing, sneezing, or blowing one’s nose If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol. Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.