FDA updates on hand sanitizers consumers should not use | FDA 74530-011-06 Posted: Jul 13, 2020 / 07:57 AM PDT. 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 1/24/2023. [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. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. 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% . Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. Safety officials at the Food and Drug Administration are warning Americans that not all hand sanitizers are made equal,. 74721-0001-7 Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Consumer and health care professional safety is a top priority for FDA, and an important part of FDAs mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply. Hand sanitizer recall: FDA list of 'do not use' products - New York Post Carcinogen found in hand sanitizer distributed by Yale This comes after a series of recalls related to. 75293-001-03 Certain hand sanitizers are being recalled because they do not meet Health Canada's requirements. It also reported that Target sold Born Basic Anti-Bac Hand Sanitizer, while Walmart sold Scent Theory at stores in 17 states. 74721-0020-9, 71120-112-01 Transliquid. Recall of certain hand sanitizers that may pose health risks (Part 1 However, consistent with FDAs temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. 74046-001-16 Still more hand sanitizers recalled: Here's a list of brands to avoid Cultivation Republic (Clearwater, Florida). 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. Dongguan Mingyi Medical Products, Co., Ltd. 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. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. Flavor Vapors, LLC, dba: Mob Liquid Labs Hand sanitizer recalled due to undeclared methanol 75821-001-03 74721-0002-7 79279-610-05 Hand sanitizer recall: FDA says Medically Minded brand found to contain Free shipping. If you have any of these 200 hand sanitizers, throw them away - BGR 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. 71120-117-02, 75821-001-01 79279-610-02 Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. Artnaturals has been added to the list. Anti-Bac Hand Sanitizer 65% Alcohol, Scent Theory Keep It Clean Pure Clean Anti-bacterial Hand Sanitizer, Cavalry (labeled with Product of Mexico), Natural Gold Gel Alcohol Antiseptic 75% Topical Solution, Command Gel AntiBac Instant hand sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily, UltraCruz Hand Sanitizing Gel Antimicrobial, Company tested product; isopropyl alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020, Sanit Technologies LLC, doing business as Durisan (Florida), Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-Free, Company tested product; contains microbial contamination; product, Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free, New Wave Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%), Company tested product; manufacturing process lacks adequate controls to prevent microbial contamination. GSD All-Purpose Anti-Bacterial Wipes | 80 Wipes per Packet In a public advisory notice. 74046-001-15 Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 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 . 79279-420-02 74046-001-06 75821-001-02 A hand sanitizer that was sold over the internet nationwide is being recalled because it may have been contaminated with toxic methanol. 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. 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. FDA Adds 4 Brands Of Hand Sanitizer To Growing Recall List Some of the products have already been recalled. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022. 74046-004-07 Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers. [8/12/2020] FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. World Health Organization formula. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. CLARKSBURG, W.Va. (WBOY) A hand sanitizer that was sold over the internet nationwide is being recalled because the company that manufactured it says it may have been contaminated with a toxic chemical. Last updated on May 17, 2022. 74046-001-08 Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. In the letter, company asked the FDA to recall the contaminated batches of hand sanitizer, conduct an investigation of the products, and provide information to the public, among other things. 75293-001-01, Coppercraft Distillery, LLC An official website of the United States government, : As of July 28, the Food and Drug Administration has recalled 87 hand sanitizer products due to the presence of methanol, a substance that can be toxic when absorbed through the skin or. Kleanz Antibacterial Hand Sanitizer Advanced, Be Safe Hand Sanitizer (labeled with Model: BF-HGXXXX-09 where XXXX changes based on packaging size), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven afterreceiving a warning letter. According to the FDA, you should use an alcohol-based hand. (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. Suite #166 Las Vegas, NV 89139";FDArecommended the company recallon11/3/2021;product voluntarilyrecalledon11/4/2021, Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer, SBL Brands LLC dba Global Sanitizers LLC(Nevada), FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Anitmicrobial Formula, Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020, WelburnGlobal SociedadAnonima(Guatemala), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven after receiving a warning letter. 74046-001-13 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. 79279-610-03 Do not pour these products down the drain or flush them. 80969-020-04 The company recalled one lot of hand sanitizer: Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. 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. 74721-0020-0 If You're Using This Hand Sanitizer, Stop Immediately Best Life $80.00. The agencys investigation of contaminated hand sanitizers is ongoing. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Updated: Jul 13, 2020 / 11:49 AM PDT. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Call Poison Help at 800-222-1222 to connect to your local poison center. 74721-0010-9 LOS ANGELES - Global Sanitizers, a wholesale producer, manufacturer and distributor of sanitizer solutions announced Thursday that is is voluntarily recalling 50,000 units of Medically Minded. 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). FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. 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 74046-004-09 FDA recommended the company recall on 06/01/2022. Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. The new additions cont The pouch is resealable to ensure your wipes are always fresh. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. 74046-001-07 The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. 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.. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. 74530-012-04 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; 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. 79279-520-08 9 best hand sanitizers meeting CDC guidance - NBC News UL did not test, certify, or approve the substance described in this SDS, and The Colorado-based company issued a voluntary recall of 20 lots of Adam's Polishes Hand Sanitizer to the consumer level in "an abundance of caution" after the FDA found one lot had contained. 74046-001-11 EO Hand Sanitizer Gel. Mint Oil Contact your local waste management and recycling center for more information on hazardous waste disposal. 79279-521-05 One product is also improperly labelled. Is being recalled by the manufacturer or distributor.