FDA MedWatch Alert: Hand Sanitizers by 4e Brands North America

MedWatch Safety Alert was added to the FDA Recalls webpage.

TOPIC: Hand Sanitizers by 4e Brands North America: Recall Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

AUDIENCE: Consumer, Health Professional

ISSUE: 4e Brands North America is recalling 10 bottle sizes (packaged in clear plastic bottles) of advanced and clear advanced hand sanitizers due to potential presence of methanol (wood alcohol). These products are used as hand sanitizers and marketed to help decrease bacteria on skin when soap and water are not available. A full listing of lot numbers in numerical order and product photos are included in the recall. To date, 4e Brands North America has not received reports of adverse events related to this recall.

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 adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.

Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. 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. The agency will provide additional information as it becomes available.

Recent recalls include:

All Clean Hand Sanitizer, Moisturizer and Disinfectant by ITECH 361

Mystic Shield Protection Topical Solution by Transliquid Technologies

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.

This chart 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, that is being recalled by the manufacturer or distributor, or that is purportedly made at the same facility as products that have 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.

Health professionals and patients 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.