Public Alert No: 001/2021 – USFDA Placed Alcohol Based Hand Sanitizers From Mexico On Import Alert To Prevent Entry Of Violative And Potentially Dangerous Products
February 5, 2021,
The National Agency for Food and Drug Administration and Control (NAFDAC) has received information that US FDA has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety.
The USFDA has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination Over the course of the ongoing pandemic.
Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.
Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and the shipment may be detained. This marks the first time the FDA has issued a countrywide import alert for any category of drug product.
Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.
Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.
Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxicity
Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning.
NAFDAC implores importers, distributors, retailers, and consumers to exercise caution and vigilance to avoid the distribution, sale and use of methanol alcohol-based hand sanitizers.
Members of the public in possession of methanol alcohol-based hand sanitizers.
are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.
NAFDAC encourages members of the public to wash their hands often with soap and water for at least 20 seconds. If soap and water are not readily available, the Nigeria Center for Disease Control and Prevention (NCDC) recommends the use of an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol or 70% isopropanol as part of the measures put in place to mitigate the possible risk of spreading the COVID 19 Virus.
NAFDAC encourages health care professionals, consumers and patients to report adverse events related to the use of any Hand sanitizer to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via email@example.com or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng