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The Food and Drug Administration (FDA) has issued an import alert for hand sanitizer products from Mexico amid serious safety concerns. The alert aims to prevent potentially harmful products from crossing U.S. borders before the FDA can review its safety.
The agency raised concerns about contamination with methanol, which is toxic when the chemical is absorbed through the skin and is life-threatening when ingested.
“As part of the import alert, Mexican alcohol-based hand sanitizers proposed for import are subject to further FDA review, and FDA personnel may withhold the sending, “said a statement released Tuesday. “As part of their entry review, FDA staff will review any specific evidence presented by importers or manufacturers that hand sanitizers were manufactured in accordance with good manufacturing practices in the United States. This is the first time the FDA has issued a nationwide import alert for a category of pharmaceutical product. “
Methanol-contaminated hand sanitizer can be toxic when absorbed through the skin and can be fatal when ingested, the FDA has warned. (iStock)
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The import alert comes amid an increase in the use of hand sanitizer during the pandemic, said Judy McMeekin, associate commissioner of regulatory affairs for the FDA. She added that action is needed to protect a safe supply of alcohol-based hand sanitizers.
Last year, the agency’s analyzes of Mexican products revealed that the vast majority (84%) did not comply with the regulations. Over 50% of the samples contained toxic ingredients, such as methanol and 1-propanol, at harmful levels.
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The FDA has warned that hand sanitizers contaminated with methanol can cause blindness, heart and central nervous system effects, hospitalizations, and death. People who ingest the products are most at risk, although application of the products to the hands can lead to methanol poisoning.
The FDA maintains a list of specific hand sanitizers to avoid, which has swelled to more than 200 products. Recent Mexican-derived hand sanitizers reported by the FDA include products from “4E Global SAPI de CV”, among other manufacturers.
“Consumers who have been exposed to a hand sanitizer contaminated with methanol and are exhibiting symptoms should contact their local poison control center and seek immediate medical treatment for a possible reversal of the toxic effects of methanol poisoning,” says the communicated.
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