August 12, 2020

Audience: Consumer, Health Professional

Update: August 12, 2020 — FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use.

Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported.

Consumers who have products on the list of hand sanitizers with potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal.

The agency continues to add certain hand sanitizers to the import alert to stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law.

FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).

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 as possible to identify the product):

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Source: FDA