FDA places alcohol-based hand sanitizers from Mexico on alert

Jan. 27, 2021

The U.S. Food and Drug Administration (FDA) has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products from entering the United States until the agency is able to review the products’ safety, the FDA said in a news release.

The FDA said this marks the first time it has issued a countrywide import alert for any category of drug product.

“Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested,” the agency said.

Under the import alert, the FDA said that alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment.

The FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84 percent of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA’s regulations. More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels, the FDA said. The agency has posted and regularly updates a list of hand sanitizer products that consumers should not use, which include those that FDA has found to contain methanol and/or 1-propanol. In most cases, methanol does not appear as an ingredient on the product label.

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