FDA Update: FDA Expands Hand Sanitizer Warnings to include 1-propanol Contamination

The FDA is warning consumers 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. After testing, they have proven to be contaminated with 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is a toxic and life threatening ingredient when ingested and is not acceptable for hand sanitizer products marketed in the United States. The FDA urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers on their website at www.fda.gov/unsafehandsanitizers. Consumers who ingest the product are most at risk because 1-propanol can cause central nervous system depression, which can result in death. Other symptoms of exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Skin or eye exposure can result in irritation, and rare cases of allergic skin reactions. If you have been exposed or are experiencing symptoms, you should seek immediate care for treatment for toxic effects of 1-propanol.

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.

FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to  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
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

For the full update, please visit the FDA’s website.

For any questions about hand sanitizers, FDA regulation and compliance, please email mdi Consultants at [email protected] RE: MedWatch.