Recalls & Warnings
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Posted February 9, 2021
Three More Hand Sanitizers Contain Toxic Ingredient
Between February 3 and 5, 2021, the FDA issued warning letters to three sellers of hand sanitizers because laboratory tests showed that their products contain methanol, which is toxic when absorbed through the skin or ingested. The products are bio aaa ADVANCE HAND SANITIZER from AAA Cosmetica, SA de CV; inatek HAND SANITIZER from Botanicals Internacional S.A. de C.V.; and CleanCare nogerm ADVANCED HAND SANITIZER from Precision Analitica Integral S.A. de C.V.
The FDA first warned consumers about the possible presence of methanol in certain hand sanitizers in June of 2020 and has continued to update consumers about potentially-affected products and recalls. In January, the FDA issued an import alert on hand sanitizers from Mexico.
More details about each of the three companies recently warned by the FDA can be found below (use the link to read the full warning letter).
- AAA Cosmetica, SA de CV: While the product labels state that bio aaa ADVANCE HAND SANITIZER contains 70% ethanol, the tests found that the product actually contained an average of 0% ethanol and 78-81% of the potentially-harmful methanol. AAA Cosmetica recalled four different hand sanitizers in July, 2020 for the same reason, including one lot of bio aaa ADVANCE HAND SANITIZER. The same product was recalled by AJR Trading LLC in September, 2020.
- Botanicals Internacional S.A. de C.V.: While the product labels state that inatek HAND SANITIZER contains 70% ethanol, the tests found that the product actually contained an average of 0.2% ethanol and 75% methanol.
- Precision Analitica Integral S.A. de C.V.: While the product labels state that CleanCare nogerm ADVANCED HAND SANITIZER contains 75% ethanol, the tests found that the product actually contained an average of 40% ethanol and 28% methanol.
These products are adulterated because the labels incorrectly state the ingredients, and they are also misbranded because they are "dangerous to health when used according to [their] labeling as a hand sanitizer."
Methanol, sometimes called wood alcohol, is poisonous. Methanol exposure through the skin or by ingestion can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The agency warned that consumers who have been exposed to hand sanitizer containing methanol to "seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning."
The FDA warned that while all individuals are at risk of harmful events if they use this product, those most in danger of methanol poisoning are children who accidentally ingest the hand sanitizer and adults who drink it as a substitute for ethanol.
Methanol is a different form of alcohol than ethyl alcohol. Hand sanitizer containing at least 60% ethyl alcohol is recommended by the CDC for disinfecting hands when soap and water are not available, and is generally considered safe when used as directed. See the CDC's website for more information about using hand sanitizer.
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