FDA urges consumers not use certain hand sanitizer products
The following chart 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 1-propanol.
- Is labeled to contain methanol.
- Has been tested and is found to have microbial contamination.
- Is being recalled by the manufacturer or distributor.
- Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.
- Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol or 1-propanol.
- Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion.
FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. Consumers can easily identify which hand sanitizer products to avoid by using the following information:
- The names of the specific manufacturers.
- NDC number, which may also be located on the product label.
- The name of the distributors that sell, or sold, or had planned to sell specific hand sanitizers products produced by these manufacturers.
Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Consumers should be aware that FDA’s recommendation against using a distributor’s specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to:
- A distributor’s products bearing the same brand name as listed below, but made by a different manufacturer
- Other products distributed by the same distributor
If a product on the list below does not identify the manufacturer on the label, consumers can contact the distributor whose name appears on the label to find out who manufactured the product. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product.
FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.
Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. Individuals with compromised immune systems are at increased risk. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization.
The agency has updated its do-not-use list of hand sanitizers to include Durisan’s contaminated hand sanitizers.
Durisan’s hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. Consumers who have products on the list of hand sanitizers with potential 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 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 is not aware of any adverse events related to Durisan’s hand sanitizer products. 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
All this information can be found at the link below. This is only a news blog informing you about news surrounding our brand. We do not take any credit for the information above. All authors and writers can be found via the link below.https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use