Hand Sanitizer from Mexico on Import Alert
The warning was issued in January from the U.S. Food and Drug Administration (FDA). More than half of the alcohol-based hand sanitizers sent to the U.S. from Mexico contain dangerous ingredients toxic to Americans. The FDA has now placed all hand sanitizers labeled as alcohol-based and made in Mexico on a countrywide “import alert.”
Young children may have been the unintended victims of more than 900 accidental poisonings which have been reported to poison control centers around the country.
The agency recalled 75 brands of hand sanitizers contaminated with methanol, or wood alcohol. When ingested through the skin, methanol can be toxic and life-threatening when ingested.
Other complications include:
- Nausea
- Blindness
- Vomiting
- Headaches
- Blurred vision
- Seizures
- Drowsiness
- Confusion
- Heart failure
Hospitalizations and deaths have resulted. It can take up to three days before the adverse health events are apparent.
Hand sanitizers are used when there is not a readily available source of soap and water to remove any exposure to the COVID-19 virus. The Centers for Disease Control and Prevention (CDC) recommends using an alcohol-based hand sanitizer with at least 60 percent ethanol, which may also appear on the label as ethyl alcohol (not methyl alcohol) or 70 percent isopropyl alcohol.
FDA Action Regarding Hand Sanitizers From Mexico
An FDA review of all hand sanitizers from Mexico from April through December 2020 revealed 84 percent of the samples were out of compliance, with more than half containing either methanol or 1-propanol at dangerous levels. Methanol is not a listed ingredient.
Instead, the labels say the product contains ethanol. Some of the labels say “FDA-approved” even though there is no hand sanitizer that has FDA approval.
FDA has been working with the retailers to recall products and remove them from store shelves.
The FDA has issued 14 warning letters to manufacturers for the misleading labels and claims. The first consumer alert letter went out in June 2020 for nine hand sanitizers made in Mexico. From May to June, 15 adults were hospitalized after ingesting the tainted products.
Some people reportedly drink hand sanitizer to get an alcohol high. Others believe ingesting hand sanitizer can disinfect the body internally. Four have died and three suffered vision impairment.
Ironically, it was the FDA that issued a call for more companies to produce over-the-counter (OTC) hand sanitizers when COVID-19 hit the country in early 2020. Looking to cash in, many manufacturers began to manufacture the product. The FDA then relaxed some regulatory requirements for these new products.
The agency then reportedly swung the other way and supplies of hand sanitizer were detained at the border as the FDA required records demanding the hand sanitizer was in compliance with Good Manufacturing Practice requirements. Some law firms are calling that too heavy handed.
Hand Sanitizer Recalls
The FDA has now expanded its recall to more than 200 different hand sanitizers allegedly containing wood alcohol. While Mexico is the main manufacturer, others are made in Guatemala, Turkey, Korea, China and six states in the U.S.
Of the 20 or more recent deaths associated with hand sanitizers, 16 involving methanol poisoning. Seven of those cases were linked directly to Mexican-made hand sanitizer.
Costco, Walmart, and CVS all sold the hand sanitizers. The FDA has not revealed to CBS News how many of the poisonous products were sold.
Data from the National Poison Data System in January shows there were 938 hand sanitizer exposure cases in ten days in January that were reported to 55 U.S. Poison Control Centers. That is a 57% increase from one year ago. Almost 600 cases involved young children under the age of 5.
Nationwide, 1,585 exposed to methanol were reported from May to August 2020, reports the American Association of Poison Control Centers.
It is a problem globally as well. Due to the popular myth that drinking hand sanitizer might clear you internally of the virus, about 800 people have died from drinking methanol, 5,900 have been hospitalized and 60 became blind, primarily in Turkey, Qatar, India, and Iran.
Recalled Brands of Hand Sanitizers
Among the 53 different Mexican manufacturers named in the recall are:
- Yacana Hand Sanitizer, 70% Alcohol.
- Blumen Advanced Instant Hand Sanitizer
- Klar and Danver Instant Hand Sanitizer
- Modesta Instant Hand Sanitizer
- Eskbiochem Hand Sanitizer
- The Honeykeeper Hand Sanitizer
- Hello Kitty Hand Sanitizer
- Assured Instant Hand Sanitizers
- Bio aaa Hand Sanitizer
- LumiSkin Advance Hand Sanitizer
- QualitaMed Hand Sanitizer
- NEXT Hand Sanitizer
- NuuxSan Instant Antibacterial Hand Sanitizer
- Modesa Instant Antiseptic Hand Sanitizer
- Argent Defense Group
- Dolphin Hands Sanitizer
- V-Klean Hand Sanitizer
- Medically Minded
- Protz Real Protection
- Alcohol Antiseptic
Consumers can check the “do-not-use” list at www.fda.gov/handsanitizerlist.
If someone ingests methanol, the antidote is an IV medicine called fomepizole which makes methanol less toxic to the body. It’s important to seek medical treatment immediately if this has happened to you or someone close to you.
Sources:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grupo-yacana-mexico-sas-de-cv-609824-01262021
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/grupo-yacana-mexico-sas-de-cv-issues-voluntary-nationwide-recall-all-lots-yacana-hand-sanitizer-due
https://www.accessdata.fda.gov/CMS_IA/importalert_1171.html
Natl Law Review
https://www.natlawreview.com/article/fda-places-all-alcohol-based-hand-sanitizers-mexico-import-alert
Morbidity and Mortality Weekly Report, August 14 2020
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