Mexican Hand Sanitizer Import Alert [US]


US FlagUS/Silver Spring: Logo - The US Food and Drug Administration ("FDA")The US Food and Drug Administration (“FDA”), a Silver Spring, Maryland-based statutory regulatory and food safety authority, places all Alcohol-based Hand Sanitizers manufactured in Mexico on a countrywide Import Alert to help stop products that appear to be in violation from entering the United States until the FDA is able to review the products’ safety.

This Import Alert was initiated due to a sharp increase in Hand Sanitizer products manufactured in  Mexico that were labeled to contain Ethanol (also known as Ethyl Alcohol) as an active agent but instead tested positive for Methanol contamination. Methanol, or Wood Alcohol, is an industrial-use substance that can be toxic when absorbed through the skin and life-threatening when ingested and can result in Nausea, Vomiting, Headache, Blurred Vision, Permanent Blindness, Seizures, Coma, permanent damage to the Nervous System and/or Death.

FDA: http://ht.ly/nBuU30ruMK9

Direct link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-place-all-alcohol-based-hand-sanitizers-mexico-import

Additional information:
The US Food and Drug Administration (“FDA”) reports its analyses of Alcohol-based Hand Sanitizers imported from Mexico found eighty-four percent (84%) of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA’s safety regulations, as follows:

  • More than half of these Alcohol-based Hand Sanitizer samples were found to contain toxic ingredients, including Methanol and/or 1-Propanol, at dangerous levels. The FDA has posted and regularly updates a list of Hand Sanitizer products that consumers should not use, and includes 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 of the recalled Hand Sanitizers. You can see this list here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use#products.

Under this Import Alert, Alcohol-based Hand Sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the Hand Sanitizers were manufactured according to US current good manufacturing practice requirements.

==> No barcodes, UPCs, NDCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this Import Alert notification.

These Alcohol-based Hand Sanitizers were known to be marketed, distributed and sold in the US states. When in doubt, please contact the manufacturer for specific product information.

Need help now? Call 9-1-1 if the person is unconscious or is having trouble breathing. Call US Poison Help toll-free at 1-800-222-1222 to connect to your local poison center. Bring the Hand Sanitizer bottle, with its contents, with you to the hospital. Learn more at https://poisonhelp.hrsa.gov/.

According to the FDA, Methanol-contaminated Hand Sanitizers are a serious safety concern in the American healthcare community. The FDA is aware of adverse events, including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health. Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Although people using these products on their hands are at risk for Methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an Alcohol Substitute are most at risk. As a result of these reported defects, you should not use any Alcohol-based Hand Sanitizers made in Mexico unless you are sure they do not contain dangerous ingredients.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug or medication, return it to your retailer for refund.

For more information, consumers should refer to the FDA’s guidelines on safe use of Hand Sanitizer, available https://www.fda.gov/consumers/consumer-updates/safely-using-hand-sanitizer as well as a question and answer page, available here: https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat Methanol and/or 1-Propanol poisonings.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact the company toll-free at 1-888-463-6332 during normal business hours Eastern Standard Time, Monday to Friday, Working members of the press/media can contact Mr. Jeremy Kahn in the FDA’s Office of Media Affairs at +1-301-796-8671 during normal business hours Eastern Standard Time, Monday to Friday or by e-mail at Jeremy.Kahn@fda.hhs.gov.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Alcohol-based Hand Sanitizers, please search for “hand sanitizer” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Methanol contamination, please search for “Methanol” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected 1-Propanol contamination, please search for “Propanol” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by US Food and Drug Administration, please search for “FDA” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14038-2021
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