The U.S. Food and Drug Administration continues to warn customers and health care workers not to use such alcohol-based hand sanitizers due to the harmful presence of methanol or wood alcohol-a material frequently used to produce fuel and antifreeze that can be hazardous when absorbed through the skin and life-threatening when ingested.
The department has also taken more measures to help discourage such hand sanitizers from reaching the U.S. by putting them on an import alert.
The FDA is working proactively with suppliers to recall products and encourages retailers to withdraw items from store shelves and online marketplaces.
A warning letter was sent to Eskbiochem S.A. as part of those actions. OF C.V. With regard to the sale of goods classified as produced at its undeclared methanol plants, false statements – including inaccurate claims that the FDA approved such products – and inappropriate manufacturing practises.
The FDA first warned in June that some of the methanol-containing hand sanitizers will be sold in retail stores and online.
Earlier this month, the agency released a further alert about an growing number of adverse outcomes including blindness, heart attacks, attacks on the central nervous system, and hospitalizations and death, mainly reported to poison control centres and state health departments.
The agency keeps seeing these figures rise.
“Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products,” said FDA Commissioner Stephen M. Hahn, M.D. “We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”
The agency has issued a do-not-use list of dangerous hand sanitizer goods, which are periodically updated.
Methanol does not turn up on the drug label in most situations.
Methanol, however, is not an appropriate ingredient in any medication, including the hand sanitizer, even though methanol is specified on the product label.
The FDA ‘s ongoing tests found methanol contamination varying from 1% to 80% in hand sanitizer products.
Importantly, the FDA advises customers not to use any of the particular manufacturers’ hand sanitizer items on the list even if the product or actual lot number is not specified because certain manufacturers only recall some – but not all – items with their hand sanitizer.
Failure by suppliers to promptly recall all potentially contaminated goods puts customers at risk of methanol poisoning.
One of the confirmed deaths is associated with Blumen Hand Sanitizer, sold through 4e North America and produced in Mexico by 4E Global, which recently extended its recall to include additional lots of its hand sanitizer items.
In addition, the FDA strongly advises manufacturers and retailers to avoid the immediate distribution and selling of hand sanitizers made by the firms on the list, even though the particular product is not included in a recall because of the possibility of methanol poisoning.
When identifying hand sanitizers from the FDA do-not-use list, consumers can check for one or more identifiers from the list corresponding to the product label, including:
- Manufacturer name
- Product name
- National Drug Code (NDC) number
If any of the identifiers (name, company, or NDC) match a product on the list, the FDA is advising consumers to stop using the hand sanitizer immediately.
Dispose of the hand sanitizer bottle, if available, in a hazardous waste bin, or disposal as suggested by local waste management and recycling centres.
Do not flush or pour down the drain these materials, or mix them with other liquids.
The exposure to methanol will lead to nausea , vomiting, headache, blurred vision, permanent blindness, epilepsy, coma, permanent nervous system damage or death.
Although people who use these products on their hands are at risk of methanol poisoning, young children who consume these products and teenagers and adults who use these products as a replacement for alcohol ( ethanol) are at greatest risk.
Consumers who have been exposed to the methanol-containing hand sanitizer and have symptoms should seek prompt medical attention to mitigate the toxic effects of methanol poisoning.