DMM Vission is recalling five lots of Cleaner Hand Sanitizer due to potential presence of methanol (wood alcohol), the U.S. Food & Drug Administration said in a statement.
The company is yet to receive any reports of adverse events involving the product.
The company noted that substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.
It also added that the maximum risk is to individuals with alcohol addiction and adolescents, who drink these products as an alcohol (ethanol) substitute. Infants and children also may unintentionally ingest the defective product and be at risk for methanol poisoning.
The recall involves Cleaner Hand Sanitizer packaged in 500 mL and 1,200 mL plastic clear bottles with white tops, bearing expiry dates of April and may 2021. They were distributed to wholesale distributors across the U.S. between April 27 and June 9, 2020.
DMM Vission has urged consumers, distributors, and retailers that have the product which is being called back to stop use or distribution and return to place of purchase.
A month ago, another Mexican company Harmonic Nature also recalled all 800 bottles of Hand Sanitizer Topical Solution packaged in 250 mL plastic bottles, due to the potential presence of 1-propanol. Mexican company Nanomateriales also recalled all lots of Zanilast+ GEL, Sanitizer gel, after the FDA laboratory analysis found that it contained 1-propanol.
The FDA continued to recall hand sanitizers, primarily made in Mexico under different brand names that have proliferated the market since the beginning of the ongoing coronavirus (COVID-19) pandemic. All these were recalled for the potential presence of undeclared menthol or 1-propanol.
Two months ago, the agency had warned consumers and healthcare workers against hand sanitizers with methanol which is cheaper than ethanol, a disinfectant. Methanol is toxic when absorbed through the skin and can be fatal if ingested.
The regulator has detained certain hand sanitizers from entering the U.S. market by placing them on import alert, on safety concerns.
The FDA first warned about methanol-containing hand sanitizers being sold in the market in June. It issued a further warning in mid-July about the rising number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death. According to the regulator, the figures continue to increase.
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