The U.S. Food and Drug Administration on Tuesday issued an unprecedented countrywide import alert on all alcohol-based hand sanitizers from Mexico, flagging them for review after 84% of samples analyzed from April through December of last year fell short of safety standards.
“This marks the first time the FDA has issued a countrywide import alert for any category of drug product,” the agency said in a statement, adding that more than half of the samples tested contained “dangerous levels” of toxic ingredients such as methanol and/or 1-propanol, rather than ethanol, the sanctioned active ingredient.
Hand sanitizer (Shutterstock/)
The FDA has posted and regularly updated 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, the FDA said.
The agency analyzed 112 samples of alcohol-based hand sanitizer products from 53 Mexican manufacturers exporting to the U.S., the FDA said in its Import Alert. That was about 60% of the total lines of alcohol-based hand sanitizer products imported from Mexico during this time period, the FDA said.
Ninety-four of the samples violated safety standards, while 18 of them, or 16%, were compliant, the FDA said. But 74 of the 94 contaminated samples contained methanol and/or 1-propanol “at unacceptable levels,” while 20 of them did not contain enough alcohol to fulfill their purpose.
“This presents serious safety concerns, as the FDA is aware of at least 20 recent deaths associated with hand sanitizers, 16 of which involved methanol poisoning,” the agency said. “Moreover, seven of these cases were directly linked to hand sanitizers manufactured in Mexico. The FDA sampled and tested shipments of the hand sanitizer products manufactured in Mexico and confirmed the presence of methanol in the products linked to each of these seven deaths.”
Last year the agency issued warnings on more than 130 hand sanitizers from various places, including Mexico, that either contained toxic ingredients or were short on alcohol, as USA Today noted. It’s also a problem elsewhere in the world, as 140,000 liters of methanol-laced hand sanitizer were seized in Europe in December.
“Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated,” said Judy McMeekin, a pharmacist and the FDA’s associate commissioner for regulatory affairs, in the agency’s statement. “Today’s actions are 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.”
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