The FDA placed all alcohol-based hand sanitizers from Mexico on import alert until it can fully review the products' safety, the agency announced Jan. 26.
During the pandemic, there has been a significant increase in hand sanitizer products imported from Mexico labeled to contain ethanol, according to the FDA. However, many of these products have tested positive for methanol contamination.
Methanol, or wood alcohol, can be toxic when absorbed through the skin, and ingestion can be fatal.
In its analyses of alcohol-based hand sanitizers imported from Mexico, the agency found 84 percent of the samples it analyzed from April through December did not comply with FDA regulations, and more than half of the samples contained toxic ingredients.
Under the import alert, alcohol-based hand sanitizers imported from Mexico are subject to "heightened FDA scrutiny," and the agency may detain shipments.
"Today's actions are necessary to protect the safe supply of alcohol-based hand sanitizers," Judy McMeekin, PharmD, the FDA's associate commissioner for regulatory affairs, said in a Jan. 27 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."
The action marks the first time the FDA has issued a countrywide import alert for any category of drug product.
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