Updated: Nov 9, 2022 / 01:55 PM EST. 74721-0002-2 Barry Butler, the owner of Tarpon Springs Distillery in Tarpon Springs, Fla., had teamed up with a nearby rum distillery to give away about 15,000 gallons of sanitizer and had made $40,000 by . 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. 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). Hand sanitizer is a great way to keep your hands clean while in public. 79279-610-05 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. 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. In late June, the agency issued a warning against purchasing. Mint Oil The site is secure. 74721-0020-8 What to do: Stop using the identified product lots below. Call Poison Help at 800-222-1222 to connect to your local poison center. 04:20. 74721-0010-9 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. GSD Advanced Hand Sanitizer. 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel Unibeleza Industria E Comercio De A company is recalling its hand sanitizers because they may contain impurities that could cause cancers through long-term exposure, according to a notice from the U.S. Food and Drug. 75821-002-02 79279-620-05. 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). Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol. Company tested product; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022 Associated lot numbers: Company tested product lot 200423322; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. The agency first warned consumers in June about hand . On June 19, 2020, the U.S. Food and Drug Administration (FDA) advised consumers not to use any hand sanitizer manufactured by "Eskbiochem SA de CV" in Mexico, due to the potential presence of methanol, a "toxic alcohol", as an active ingredient, which can cause blindness and/or death when absorbed through the skin or when swallowed. 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): [8/7/2020] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDAs temporary policies to help ensure that harmful levels of methanol are not present in these products. 71120-112-10 Do not pour these products down the drain or flush them. This recall is being conducted with the knowledge of the FDA. 79279-620-03 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 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. 80969-020-03 74721-0020-7 74046-004-03 Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. 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. 33.8 oz. Never eat or drink hand sanitizers, as swallowing even small amounts can be dangerous or fatal. 74046-001-12 Contact your local waste management and recycling center for more information on hazardous waste disposal. FDA recommended the company recall all drug products on 12/12/2022. That chemical, according to the recall posted on the U.S. Food and Drug Administration's website, is . 74721-0010-5 Suite #166 Las Vegas, NV 89139" FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion;Product labeled as handsanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. FDA recommended the company recall on 06/01/2022. Aloe Vera Based Hand And Skin Purifying Gel. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. 74046-006-10. 74721-0002-5 74530-012-05 79279-521-04 Certain hand sanitizers are being recalled because they do not meet Health Canada's requirements. 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. On Nov. 7, the FDA announced that Colorado-based Adam's Polishes, LLC had issued a voluntary recall for 20 lots of its Adam's Polishes Hand Sanitizer. 74046-001-08 You should look for lot number 1166A and expiration date 6/18/2023 on the container. 74530-012-03 Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 74721-0001-7 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 ones nose. Free shipping. Before sharing sensitive information, make sure you're on a federal government site. 74046-001-16 Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. 74530-012-04 Cultivation Republic (Clearwater, Florida). The agency also included an additional denaturant formula in the temporary guidances. The .gov means its official.Federal government websites often end in .gov or .mil. The US Food and Drug Administration has expanded its warning about hand sanitizers to avoid, with the list now topping 100. 74046-001-04 74721-0001-2 Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Dongguan Mingyi Medical Products, Co., Ltd. ], Alcohol Antiseptic 75% Topical Solution Hand Sanitizer, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to, Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico), HF&N Lab Medi Care Alcohol Antiseptic Topical Solution, 77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, SBL Brands LLC dba Global Sanitizers LLC (Nevada), Alcohol Antiseptic 70% Solution or 80% Solution, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to, TriCleanz (labeled with Made in Mexico), TriCleanz Tritanium Labs Hand Sanitizer (labeled with Made in Mexico), Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Industrias Cklass Foaming Hand Sanitizer with Aloe, Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to, Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinmicas S de RL de CV (Mexico), Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, MVP Sanitizing Services Spray Hand Sanitizer, Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily, Leipers Fork Distillery Bulk Disinfectant per 5 gallon and Leipers Fork Distillery 16 oz bottle, Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to, Liqesa Exportacion or Liq-E-SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to, Optimus Lubricants Instant Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to, The Crme Shop Moisturizing Hand Sanitizer, Peppermint Scented, FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to, Company tested product; contains methanol; product voluntarily recalled by, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily, Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily, Neoingenium Labs SA de CV Hand sanitizer (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to, Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China), Best Brand Consumers Products, Inc. (New York), Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022;added manufacturer to, FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations, Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to, FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Noticias Mexico Hoy Grupo Multimedia (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to, Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; added manufacturer to, Product purported to be made at the same facility that produced subpotent product; added manufacturer to, Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer, Real Clean Distribuciones SA de CV (Mexico), Born Basic.