FDA updates on hand sanitizers consumers should not use
FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDA’s temporary guidances.
Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. USP’s revision bulletin for alcoholExternal Link Disclaimer and dehydrated alcoholExternal Link Disclaimer monographs outlines this testing requirement, official as of September 1, 2020, which FDA requestedExternal Link Disclaimer to protect health care providers and consumers from using dangerous hand sanitizer products.
The agency’s investigation of contaminated hand sanitizers is ongoing.
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 .
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.
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