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FDA: All Alcohol-Based Hand Sanitizers From Mexico on 'Import Alert'

WEDNESDAY, Jan. 27, 2021 -- All alcohol-based hand sanitizers from Mexico have been put on "import alert" until their safety can be assessed, the U.S. Food and Drug Administration says.

During the COVID-19 pandemic, there has been a large increase in hand sanitizers from Mexico that are labeled to contain ethanol (also known as ethyl alcohol) but have tested positive for methanol contamination, according to the agency. Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs, the FDA said. Under the import alert, alcohol-based hand sanitizers from Mexico will come under closer FDA scrutiny, and agency staff may detain shipments.

This is the first time the FDA has issued a countrywide import alert for any category of drug product. The FDA said 84 percent of samples of alcohol-based hand sanitizers imported from Mexico that were analyzed by the agency from April through December 2020 did not comply with FDA regulations. More than half of the samples contained dangerous levels of toxic ingredients, including methanol and/or 1-propanol. A regularly updated list of hand sanitizers that consumers should not use can be found on the FDA website.

"Today's actions are necessary to protect the safe supply of alcohol-based hand sanitizers," Judy McMeekin, FDA associate commissioner for regulatory affairs, said in an agency news release. "We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U.S. consumers in mind."

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