“The agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the US until the agency is able to review the products’ safety,” the release said on Tuesday.
The decision followed an examination of 112 samples of alcohol-based hand sanitizer products from 53 different Mexican manufacturers. Of 94 samples judged to be deficient, 74 had excessive levels of methanol and/or 1-propanol - two poisonous types of alcohol that can be absorbed through skin, the release said.
“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. Moreover, seven of these cases were directly linked to hand sanitizers manufactured in Mexico,” the release stated.
Another 20 samples had "insufficient levels of active ingredient – non-poisonous ethyl alcohol - to be effective,” the release added.
An Import Alert allows inspectors to seize shipments of Mexican sanitizer from companies that fail to qualify for an FDA certified “Green List” of manufacturers that meet US requirements. Hand sanitizers are regulated in the United States as non-prescription drugs for external use, according to the release.