FDA places hand sanitizer products from Mexico on import alert
The Food and Drug Administration (FDA) has placed all alcohol-based hand sanitizers from Mexico on import alert due to methanol contamination.
The agency said in a statement Tuesday that over the course of the coronavirus pandemic, it has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol, or ethyl alcohol, but actually tested positive for methanol.
Under import alert, the products are subject to heightened scrutiny, and staff may detain shipments of products.
This is the first time the agency has issued a countrywide import alert for any category of drug product.
FDA Associate Commissioner for Regulatory Affairs Judy McMeekin said in a statement that the import alert was “necessary to protect the safe supply of alcohol-based hand sanitizers.”
“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,” McMeekin said.
The agency said 84 percent of samples analyzed between April and December were not in compliance with the FDA’s regulation, and more than half were found to contain ingredients like methanol and/or 1-propanol at “dangerous levels.”
Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when injected.
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