FDA reiterates warning about hand sanitizers with methanol

July 29, 2020

The U.S. Food and Drug Administration (FDA) continues to warn consumers and healthcare professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin, as well as life-threatening when ingested, according to reports on the FDA website.

The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that the FDA approved these products – and improper manufacturing practices.

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June. The agency issued a further warning earlier this month about an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily reported to poison control centers and state departments of health. The agency continues to see these figures rise.

The FDA has posted a do-not-use list of dangerous hand sanitizer products, which is being updated regularly. In most cases, methanol does not appear on the product label. However, methanol is not an acceptable ingredient in any drug, including hand sanitizer, even if methanol is listed as an ingredient on the product label. The FDA’s ongoing testing has found methanol contamination in hand sanitizer products ranging from 1 percent to 80 percent.

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