FDA MedWatch: Harmonic Nature Hand Sanitizer by Harmonic Nature S. De R.L.M: Recall

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: Harmonic Nature Hand Sanitizer by Harmonic Nature S. De R.L.M: Recall – Due to Presence of 1-Propanol AUDIENCE: Consumer, Health Professional ISSUE: Harmonic Nature S. De R.L. Mi is recalling all 800 bottles of 250 mL Harmonic Nature hand sanitizer due to the presence of 1-propanol based on test results. Do not use any products on this list of hand sanitizers with potential methanol or propanol contamination, and continue checking this list often as it is being updated daily. This list outlines the information on hand sanitizer labels for consumers to use to identify a product that has been tested by FDA and found to contain methanol or propanol. FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers. The agency will provide additional information as it becomes available. Harmonic Nature has not received any reports of adverse events related to this recall. BACKGROUND: Harmonic Nature is used as a hand sanitizer and can be identified as hand sanitizer Topical Solution packaged in 250 mL plastic bottles. PRODUCTS BEING RECALLED: 250 mL plastic bottles UPC 7500462892210

RECOMMENDATION: 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      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. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.