FDA PUTS ALL MEXICAN-MADE HAND SANITIZERS ON IMPORT ALERT DUE TO DANGEROUS INGREDIENT

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By Miriam Raftery

January 28, 2021 (San Diego) – Over half of all hand sanitizers from Mexico have been found to contain toxic ingredients, many at dangerous levels, and 84% of samples tested failed to comply with FDA regulations. So on January 26, the FDA announced a nationwide import alert on all hand sanitizers made in Mexico to prevent them from entering the US. Until the agency can review products’ safety.

This is the first time the FDA has issued a country-wide alert for any category of drug product. Many of the Mexican-made hand sanitizers contain methanol (wood alcohol), which is toxic when absorbed through the skin and life-threatening with ingested, or propanol, another dangerous substance.

The  FDA reports methanol poisoning from these products has caused blindness, heart trouble, effects on the central nervous system, hospitalizations and death, primarily reported to poison control centers and state departments of health. Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. 

Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol substitute are most at risk. 

Consumers who have been exposed to hand sanitizer contaminated with methanol and are experiencing symptoms should contact their local poison control center and seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning.

The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information to identify the product as possible). For more information, consumers should refer to the FDA’s guidelines on safe use of hand sanitizer as well as a question and answer page.

Need help now? Call 9-1-1 if the person is unconscious or has trouble breathing. Call Poison Help at 800-222-1222  to connect to your local poison center. Learn more at https://poisonhelp.hrsa.gov/.  

"Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated," said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs. “Today’s actions are necessary to protect the safe supply of alcohol-based hand sanitizers. We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U.S. consumers in mind.” 

The FDA previously issued 14 warning letters since March 2020, but violations continue with products falsely labeled as containing ethanol, a safe and approved ingredient for topical use, when in fact they contain toxic methanol. 

The FDA continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers. The agency reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination.

 

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