Recalls & Warnings
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Posted March 2, 2021
FDA Warns Makers of Four Hand Sanitizers, Two With Toxic Ingredient
Between February 18 and 25, 2021, the FDA issued warning letters to four sellers of hand sanitizers because laboratory tests showed that their products do not contain the amount of ethanol as stated on their labels. The products are FRAGRANCE FREE VLANC + PLUR HAND SANITIZER RINSE FREE FORMULATED WITH 70% OF ALCOHOL WITH ALOE VERA & GLYCERIN from Absara Cosmetics S.A.P.I DE C.V.; ARGENT Defense Group HAND SANITIZER from Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.; DAESI Hand Sanitizer from Yara Elena De La Garza Perez Nieto; and Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution from Inovaker Lab S.A. de C.V. Two of these products were found to contain methanol, which is toxic when absorbed through the skin or ingested.
The FDA first warned consumers about adulterated hand sanitizers in June of 2020 and has continued to update consumers about potentially-affected products and recalls.
More details about each recently-warned company can be found below (use the link to read the full warning letter).
- Absara Cosmetics S.A.P.I DE C.V.: While the product labels state that FRAGRANCE FREE VLANC + PLUR HAND SANITIZER RINSE FREE FORMULATED WITH 70% OF ALCOHOL WITH ALOE VERA & GLYCERIN contains 70% ethanol, the tests found that the product actually contained an average of 58% ethanol.
- Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.: While the product labels state that ARGENT Defense Group HAND SANITIZER contains 70% ethanol, the tests found that the product actually contained an average of 0.07% ethanol and 66% methanol.
- Yara Elena De La Garza Perez Nieto: While the product labels state that DAESI Hand Sanitizer contains 70% ethanol, the tests found that the product actually contained a different amount of ethanol and also contained methanol. The warning letter did not specify the amounts of each substance.
- Inovaker Lab S.A. de C.V.: While the product labels state that Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution contains 75% ethanol, the tests found that the product actually contained 0% ethanol. The warning letter did not specify what the product's true contents.
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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