79279-620-05. Company tested product; contains benzene. Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. 74046-001-10 74046-006-03 74721-0001-5 79279-521-02 [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. (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. World Health Organization formula. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Sophora Extract 75821-001-03 Company has not responded 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 08/16/2022. To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. Now, about five dozen different. The United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on September 1, 2020, and established a limit for methanol in alcohol of 200 parts per million (ppm). No rinse needed, usable anywhere without water. 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. One product is also improperly labelled. Cosmeticos Ltda, (Brazil), Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant, 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 10/18/2022, Reborncare Hand Sanitizer (100mL, 250mL, 500mL). Free shipping. 74721-0020-7 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. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. FDA recommended the company recall on 9/20/2021;product voluntarily recalled on 9/21/2021, SBL Brands LLC dba Global Sanitizers, LLC (Nevada), Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA issued a, Scentsational Soaps and Candles Inc. (Florida), Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution, Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily, Fresh Lemon Citron Frais Scented Hand Sanitizer, SS Black and White Collection and Photo Real Collection: Coconut Breeze; Eucalyptus & Mint; Lavender & Herbs; Lemon Zest; Tangerine & Guava, Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 1/20/2022; product voluntarily recalled on 1/28/2022. The .gov means its official.Federal government websites often end in .gov or .mil. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. Transliquid. 80969-010-07 Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. FDA issued a, Virgin Scents dba artnaturals (Gardena, CA), FDA tested product; contains unacceptable levels of benzene, acetal, and acetaldehyde; FDA recommended the company recall on 10/8/2021; FDA also recommended artnaturals test additional lots to determine the scope of the contamination; certain lots voluntarily, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as hand sanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. 74046-001-14 74721-0020-9, 71120-112-01 74721-0001-3 79279-521-01 Harmonic Nature S de RL de MI (Mexico) FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added to import alert to stop products from entering the U.S. on 8/20/2020; product voluntarily recalled on 8/14/2020. GSD Advanced Hand Sanitizer. 74046-006-05 CNN Two lots of Disney-branded hand sanitizer featuring Mickey Mouse and baby Yoda from The Mandalorian have been voluntarily recalled by Best Brands Consumer Products, according to a. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Health Canada has recalled the following products . Hand sanitizer is a great way to keep your hands clean while in public. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 74721-0002-6 79279-520-07 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Call Poison Help at 800-222-1222 to connect to your local poison center. GSD All Purpose Liquid Sanitizer & Disinfectant MEGA REFILL SIZE 1.75L (59.2 OZ) 80% ALCOHOL GSD All Purpose Liquid Sanitizer & Disinfectant FAMILY SIZE 1L (33.2 OZ) 80% ALCOHOL GSD All Purpose Liquid Sanitizer & Disinfectant POCKET SIZE 375mL (12.6 OZ) 73% Alcohol - Gel Sanitizer & Disinfectant With Essential Oils 73% ALCOHOL 79279-421-10 CNN . Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021. Never eat or drink hand sanitizers, as swallowing even small amounts can be dangerous or fatal. USPs revision bulletin for alcohol and dehydrated alcohol monographs outlines this testing requirement, official as of September 1, 2020, which FDA requested to protect health care providers and consumers from using dangerous hand sanitizer products. The FDA listed the following products in its warning: All-Clean Hand Sanitizer (NDC: 74589-002-01) Esk Biochem Hand Sanitizer (NDC: 74589-007-01) CleanCare NoGerm Advanced Hand Sanitizer 75% . Tennessee Technical Coatings Corp. is voluntarily recalling all lots of its isopropyl alcohol antiseptic 75% hand sanitizer. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The Food and Drug Administration has recalled more hand sanitizers with a new, deadly toxin bringing its growing "do not use" list to nearly 150 products. Acetal can irritate the upper respiratory tract, eyes, and skin. 74530-013-05 79279-610-04 Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. 74046-001-18 The newest recalled hand sanitizers are: Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. 74721-0001-6 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. Pleasant scent and safe for sensitive skin. 74530-015-05 Five more hand sanitizers were added to Health Canada's evolving recall list on Tuesday, which now includes more than 100 products that may pose health risks. 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. 74530-015-06, 74530-011-01 In late June, the agency issued a warning against purchasing. The hand sanitizers include brands sold at Sam's Club and BJ's Wholesale Club. An independent pharmacy and lab conducted a study of hand sanitizers sold during the pandemic and found that samples from 44 of them contained benzene, a chemical known to cause leukemia. 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 FDAs temporary guidances. 71120-112-08 74046-001-16 Need help now? According to the FDA, you should use an alcohol-based hand. 80969-007-01 74046-006-02 74530-015-04 FDA encourages health ce professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product): [7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer productsthat are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. This comes after a series of recalls related to. 74721-0001-9 75293-001-03 71120-117-02, 75821-001-01 The company announced the recall on Mar. 70% Alcohol Cleansing Gel Say Goodbye to Germs. 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). For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. 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 9/2/2022. 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). product voluntarilyrecalledon 11/30/2021, Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021, 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, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. 79279-520-08 It was distributed nationwide to wholesale distributors and retailers. (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 The company recalled one lot of hand sanitizer: Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. [3/25/2021] 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. Health Canada has recalled several hand sanitizers across the country over the last two years over concerns of potential health risks from using the products. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. 75339-751-06, Dongguan Chunzhen Biological Technology Co., Ltd(China), GuangdongLongtaiIndustry Co., Ltd.(China), 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 07/05/2022, GuangdongLongtaiIndustry Co., Ltd.(China), 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 07/06/2022, Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China), Guangzhou Minghui Cosmetics Co. Ltd.(China). 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. 74046-001-12 7 and the U.S. Food&Drug . A hand sanitizer made by nanoMaterials Discovery Corp. has been recalled because the U.S. Food and Drug Administration said it "may exceed FDA limits for methanol." Snowy Range Blue alcohol . Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 75821-001-04 Consumers who have products on thelist of hand sanitizerswith potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 74721-0002-2 The agency tweeted on Monday about the two latest recalls. Last updated on May 17, 2022. 79279-521-05 Has been tested and is found to have microbial contamination. 71120-112-06 Hand Sanitizer Sold Nationwide Recalled Due to Health Concerns, FDA Warns Even though it's long been available to customers, the COVID-19 pandemic certainly changed the rate at which we buy. [10/28/2021] FDA is alerting health care professionals and consumers of artnaturals voluntaryrecall of limited batches of 8 oz bottles of Scent Free Hand Sanitizer. 80969-008-01, 80969-010-01 74530-012-03 74046-006-07 FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAsMedWatch Adverse Event Reportingprogram (please provide the agency with as much information as possible to identify the product): [1/19/2021] Today, FDA issued a guidance outlining the agencys policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. The agency has recalled hand sanitizers from the companies All-Clean, Eskbiochem, CleanCare, Saniderm, Lavar 70 and Good Gel, which were all manufactured by Mexico-based Eskbiochem SA de CV.. 74721-0010-4 74530-015-03 Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. Antibacterial Hand Sanitizer with Moisturize, Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. (China), Guangdong JunBao Industry Co. Ltd. (China), JPR Medical Disinfecting Wipes (75% alcohol), Guangdong JunBao Industry Co., Ltd. Zorin Pharmaceutical Technology Co. Ltd. (China), 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 10/12/2022, Biotipo Pharma Medical Sanitizing Hand Wipes, PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil.