FDA Updates on Hand Sanitzers with Methanol

FDA Updates on Hand Sanitzers with Methanol

 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol

7/2/2020: UPDATE - FDA warns consumers of risk of methanol contamination in certain hand sanitizers

[7-2-2020] 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. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.

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. The agency will provide additional information as it becomes available.

Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. 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 for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.

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; and 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 (also referred to as ethyl alcohol).

FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:

• The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products. 
• Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
• Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
• Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
• Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.

FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178. 

FDA’s testing and manufacturer’s recalls

The following 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,  that is purportedly made at the same facility as products in which FDA has tested and confirmed methanol contamination and/or that has been identified through the agency’s registration and listing database. FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers.

Company Company Product(s) NDC Product status Grupo Insoma, S.A.P.I de CV (Mexico) Hand sanitizer Gel Unscented 70% Alcohol 75744-0200-3 75744-0200-4 75744-0201-5 75744-0202-1 75744-0250-1 75744-0250-2 75744-0500-1 75744-1000-1 75744-1000-3 75744-1001-1 FDA tested product; contains  methanol; FDA recommended a recall on 07/01/2020 Transliquid Technologies (Mexico) Mystic Shield Protection hand sanitizer 75477-435-02 75477-435-10 75477-435-12 75477-435-25 75477-435-50 75477-534-10 Contains methanol Soluciones Cosmeticas SA de CV (Mexico) Bersih Hand Sanitizer Gel Fragrance Free 75165-003-02 75165-004-01 75165-005-01 75165-006-01 75165-008-01 75165-250-01 75165-600-01 FDA tested product; contains  methanol; FDA recommended a recall on 07/01/2020 Soluciones Cosmeticas SA de CV (Mexico) Antiseptic Alcohol 70% Topical Solution hand sanitizer Not listed FDA tested product; contains methanol; FDA recommended a recall on 07/01/2020 Tropicosmeticos SA de CV (Mexico) Britz Hand Sanitizer Ethyl Alcohol 70% 76676-402-01 77676-402-02 77676-402-03 77676-402-04 77676-402-05 77676-402-06 77676-402-07 77676-402-08 77676-402-09 77676-402-10 77676-402-11 77676-402-12 77676-402-13 77676-402-14 77676-402-16 77676-402-17 77676-402-18 77676-402-19 77676-402-20 FDA tested product; contains  methanol; FDA recommended a recall on 07/01/2020 Eskbiochem SA de CV (Mexico) All-Clean Hand Sanitizer 74589-002-01 Product purported to be made at the same facility Eskbiochem SA de CV (Mexico) Esk Biochem Hand Sanitizer 74589-007-01 Product purported to be made at the same facility Eskbiochem SA de CV (Mexico) Lavar 70 Gel Hand Sanitizer 74589-006-01 FDA tested product; contains methanol Eskbiochem SA de CV (Mexico) The Good Gel Antibacterial Gel Hand Sanitizer 74589-010-10 Product purported to be made at the same facility Eskbiochem SA de CV (Mexico) CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol 74589-005-03 Product purported to be made at the same facility Eskbiochem SA de CV (Mexico) CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol 74589-009-01 FDA tested product; contains methanol Eskbiochem SA de CV (Mexico) CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol 74589-003-01 Product purported to be made at the same facility Eskbiochem SA de CV (Mexico) Saniderm Advanced Hand Sanitizer 74589-001-01 Product purported to be made at the same facility; product recalled by Saniderm Products and UVT Inc.