Recalls & Warnings
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Posted March 16, 2021
Albek de Mexico Hand Sanitizer Contains Dangerous Ingredient
On March 11, 2021, the FDA issued a warning letter to Albek de Mexico S.A. de C.V. because laboratory tests showed that their product NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER contains methanol, which is toxic when absorbed through the skin or ingested.
The FDA warned first 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.
Albek de Mexico announced a recall of NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER in July, 2020, but FDA tests showed the continued existence of methanol.
While the product labels state NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER contains 70% ethanol, the tests found that the product actually contained a range of 37-55% ethanol and 10-29% of the potentially-harmful methanol. This product is adulterated because the label incorrectly states the ingredients, and it is also misbranded because it is "dangerous to health when used according to its 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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