FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. 74530-011-07 Dongguan Mingyi Medical Products, Co., Ltd. Category: Hand Sanitizer. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. 74721-0010-5 List of antiseptic or antibacterial skin cleansers or hand sanitizers meeting Health Canada's requirements for safety, effectiveness and quality, for use against coronavirus (COVID-19). 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). The hand sanitizers include brands sold at Sam's Club and BJ's Wholesale Club. 79279-421-06 On March 26, students, faculty and staff were notified in an email from Yale's Environmental Health & Safety Department, or EHS, that benzene, a substance that can cause cancer, was detected in two hand sanitizer brands distributed by Yale, CleanHands and ArtNaturals, and were asked to dispose of the hand . (Florida), Salon Technologies International Sanitizing Hand Spray 80%. The Food and Drug Administration has expanded the list of hand sanitizers some sold at Walmart, Costco and other national chains being recalled to at least 75 recently, saying toxic. Aloe Vera Based Hand And Skin Purifying Gel. 80969-020-03 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 Health Canada has issued a recall for 19 hand sanitizers because they may pose health risks. $19.95. 75339-751-03 74721-0020-6 Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 75821-001-02 GSD Disinfecting Sanitizing Wipes can be used for everyone. 74530-013-05 Consumers can easily identify which hand sanitizer products to avoid by using the following information: 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. 71120-611-08 74721-0020-8 FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 11/29/2022. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. A hand sanitizer that was sold over the internet nationwide is being recalled because it may have been contaminated with toxic methanol. Free shipping. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023, 74046-004-01 (NEXSTAR) American Screening LLC is voluntarily recalling 153,336 units of hand sanitizer that are packaged in containers that look like water bottles and pose a risk of consumption. Updated: Nov 9, 2022 / 01:55 PM EST. The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including, but not limited to, purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol, and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. Alcohol Free Disinfectant, Safe Cleaner Plus The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk. 75293-001-03 Innovaciones Tecnologicas Concar, SA de CV Do not pour these products down the drain or flush them. 74721-0001-8 Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. Hand sanitizer is a great way to keep your hands clean while in public. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP). Oct 9 2021, 10:23 am. 74530-013-06 Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. 71120-117-02, 75821-001-01 Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. 74046-001-09 MIAMI (CBSMiami) - The Food and Drug Administration has added four brands of hand sanitizer to a list of more than 75 that have been recalled. Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L), Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml), Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution. Transliquid. 74046-001-02 Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 75821-002-02 74721-0020-2 74530-011-02 Company tested product; contains benzene. The company recalled one lot of hand sanitizer: Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. FDA issued a, Yara Elena de La Garza Perez Nieto (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added manufacturer to, Product labeled to be edible alcohol; added manufacturer to. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Tennessee Technical Coatings Corp. is voluntarily recalling all lots of its isopropyl alcohol antiseptic 75% hand sanitizer. Herbacil Antiseptic Hand Sanitizer 70% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily, Soho Fresh Hand Sanitizer Gel Antibacterial, FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to, SOHO Fresh Hand Sanitizer Gel Antibacterial, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by, CALA Advanced Hand Sanitizer with Aloe Vera Extract, FDA-tested product; contains benzene; FDA recommended the company recall Lot 2004718 (Expiration 04/2023) on 12/27/2021; FDA expanded recall on 2/25/2022 to include all hand sanitizer drug products manufactured at the facility; added manufacturer to, Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced, FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, DEPQ Internacional S de RL de CV (Mexico), FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, dgreen Advanced Hand Sanitizer Antibacterial Gel, Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to, FDA tested product; contains methanol; addedmanufacturerto, Product purported to be made at the same facility that produced methanol contaminated product; addedmanufacturerto, Distribuidora Lagunera del Norte SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Distribuidora Lagunera del Norte SA de CV, FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, Cleaner by Crystalware Hand Sanitizer Alcohol Gel, FDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to, The Good Gel Antibacterial Gel Hand Sanitizer, CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, Estrategia Hospitalaria SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to, Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to, Genesis Partnership Company SA (Guatemala), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to. 74530-011-08, 74530-013-01 74721-0020-0 A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. The company, Spartan Chemical, issued a recall for its "Lite 'n Foamy Lemon Blossom Hand Sanitizer" and "foamyiQ Lemon Blossom Hand Sanitizer" on July 1. HAND SANITIZER Isopropyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; contains benzene; FDA recommended the company recall Lot 200324 (expiration date unknown) on 03/30/2022, Product labeled to contain methanol; FDA recommended the company recall on 11/18/2021. An official website of the United States government, : 74046-006-02 74721-0002-9, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022, Safe Cleaner K (Nevada), Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022, Salon Technologies International Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023. It was distributed nationwide to wholesale distributors and retailers. The FDA has published a long list of hand sanitizers that they do not recommend for use. To help limit the spread of COVID-19, wash your hands often with soap and water for at least 20 seconds. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. The .gov means its official.Federal government websites often end in .gov or .mil. Consult your health care professional if you have used any of these products and have health concerns. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 74046-006-05 The agency continues to add certain hand sanitizers to theimport alertto stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law. Unibeleza Industria E Comercio De 79279-420-03 Real Clean Distribuciones has recalled its Scent Theory Keep Clean and Keep It Clean, Born Basic, and Lux Eoi hand sanitizers, The Miami Herald found. Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021. Updated: Jul 13, 2020 / 11:49 AM PDT. Florance Morris Body Care Antispetic Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to, M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to, Hand Sanitizer Alcohol Antiseptic topical solution 80%, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Jalisco Paper Inc. Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. Cultivation Republic (Clearwater, Florida). The agency tweeted on Monday about the two latest recalls. The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death. 74046-004-09 79279-620-04 Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Family size (1 L), Good Spirits Distilling Advanced Hand Sanitizer. 79279-421-07 FDA remindsconsumersto 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 ones nose. 80969-007-01 If soap and water are not readily available, theCenters 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).
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