Safety Information In addition, a Cosmetic Ingredient Review (CIR) expert scientific panel states that benzophenone and its derivatives (benzophenone-1, -3, -4, -5, -9 and -11) are safe as typically used in cosmetics and personal care products. Gigi's Goodbye Germs Hand Sanitizer. between May 11, 2020 and July 19, 2020. 18 Hand Sanitizers Products Recalled Due to Excessive Amount of Methanol: It is recommended to use hand sanitizers with at least 60% ethanol alcohol or 70% isopropanol. Moisture infused. Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. FairPrice Hand Sanitiser Lavender (Batch: 201251-001) 16. germ-X Advanced Hand Sanitizer Original Scent (all batches) 17. CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol. The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: Has been tested . Polyethylene Glycol Compounds (PEGs) are utilized for their thickening, softening, and penetration-enhancing properties. 74721-0001-0 Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours). You can find details of this announcement on the HSA website. Is being recalled by the manufacturer or distributor. Uncategorized. It not only kills 99.99% germs instantly, but also boosts you immunity for upto 10 hours. HAND SANITIZER SPRAY 100 ML / HANDSANITIZER SPRAY 100 ML. Learn more at poisonhelp.hrsa.gov/. The recalls were carried out on a Class 2 level, which is a wholesale level. About Lifebuoy. While USP has not yet updated the Isopropyl Alcohol Monograph to include a specific methanol limit, FDA may consider the 200 ppm methanol limit for ethanol to also be suitable for isopropyl alcohol. This is different from a consumer level recall where the products or batches are recalled from patients, consumers, wholesale suppliers, retail suppliers, hospitals, clinics, and pharmacies, or a retail level recall, where products or batches are recalled fromretail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers. The site is secure. 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. [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. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination. LIFEBUOY HAND SANITIZER alcohol gel: Product Information: Product Type: HUMAN OTC DRUG: Item Code (Source) NDC:73931-006: Route of Administration: TOPICAL: . Topical Solution. 71120-611-07 This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. FDA is not aware of any adverse events related to Durisans hand sanitizer products. The product was tested under HSAs product quality surveillance programme and was found to contain acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit. LIFEBUOY HAND SANITIZER75 PERCENT- alcoholgel 74530-011-08, 74530-013-01 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. 71120-112-05 74530-013-07 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 09/27/2022; product voluntarily recalled on 9/27/2022. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. SINGAPORE 159545, AsepsoProfessional Hand Sanitiser (Batch: B42M), Epi KleenGel Hand Sanitizer Gel (all batches), Guardian Lavender & Passion Flower Antibacterial Hand Sanitiser (Batch: 9K28DF), Guardian Aloe & Korean-Mint Antibacterial Hand Sanitiser (Batch: 0D32DF), Kundal Fresh Water Hand Sanitizer+ (Batch: BN227), Sanitelle Instant Hand Sanitizer Antiseptic Gel Kids (all batches), Cath Kidston Moisturising Hand Sanitiser (all batches), Redmoon Bacteriostat Wash Free Hand Wash Gel (all batches), We11 Daily Instant Hand Sanitiser (all batches), Cool Days Peppermint Instant Hand Sanitizer (all batches), Walch Instant Hand Sanitizer (Batch: TG01), Lifebuoy Instant Hand Sanitizer (Batch: OD13UL), FairPrice Hand Sanitiser Lavender (Batch: 201251-001), germ-X Advanced Hand Sanitizer Original Scent (all batches), Sanigen Gel Hand Refreshing Gel 600ml (all batches), Yuri Hand Gel Green Tea Extract (all batches). Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 70% Alcohol Cleansing Gel Say Goodbye to Germs. The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDAs temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. 74530-012-06 75821-001-02 Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. Just apply to hands and rub until dry. Hand sanitizer. But according to the FDA, some of the hand sanitizers on the market contain a toxic ingredient -- methanol -- that is dangerous when ingested or absorbed through the skin, and can be fatal in large quantities. For use when soap and water are not available. 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. Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) 15. Health & Hygiene. This link opens a new browser tab . Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 FDA will consider revising the list as appropriate. Made in Korea. 74721-0001-6 Rub hands together until dry - Supervise children under 6 years of age when using this product to avoid swallowing. This chemical is found in up to 40% of products. Soothing. 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. When using this product keep out of eyes, ears, and mouth. 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. 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. 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. In case of contact, rinse eyes thoroughly with water. FDA recommended the company recall on 06/01/2022. Small doses of triethanolamine are approved, but too much will be harmful. 75339-751-05 Company tested product lot 2004090090; 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. 74530-012-07 The hand sanitisers that are affected are as follows: This has been classified as a Class 2 recall by HSA, which is reserved for recalls of products with issues that would not likely cause serious adverse health outcomes. Guangzhou Minghui Cosmetics Co. Ltd. (China), Product purported to be made at the same facility that produced subpotent ethyl alcohol product;added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued awarning letteron 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021, Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. 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 5/16/2022; FDA issued a warning letter on 07/20/2022. 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. These may be signs of a serious condition. Which hand sanitizers are being recalled in Canada? FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022. Odor neutralizing. 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. 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. UNILEVER ASIA PRIVATE LIMITED. An official website of the United States government, : Skin friendly hence, can be used frequently where soap and water hand washing is not available. Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to, Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to, Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution, Smart Care hand sanitizer packaged in 0.84 fl oz. Peak Processing Solutions - Ethanol sanitizer 80%. 74721-0010-2 alcohol gel. Contact your local waste management and recycling center for more information on hazardous waste disposal. 74721-0020-9, 71120-112-01 The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohols source. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Route of Administration. 74721-0002-2 Medline Plus . For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 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. Rub hands together until dry. 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. 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). 75339-751-04 74530-011-02 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). Consumers should be aware that FDAs recommendation against using a distributors specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to: 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. 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. Comprehensive antimicrobial activity for hygienic hand disinfection within 30 seconds. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. Sterillium is the classic among the alcohol-based disinfectants for hygienic and surgical hand disinfection. 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 09/09/2022. Acetal can irritate the upper respiratory tract, eyes, and skin. Before sharing sensitive information, make sure you're on a federal government site. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. 201 HENDERSON ROAD an essential oil, such as tea tree oil or lavender oil, or you can use lemon juice instead. 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. Boost your hand hygiene and immunity to keep fighting germs. A asiafrenz High Supremacy Member 74530-011-05 Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. (China). The FDA has advised consumers not to use this hand sanitizer. 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). 74721-0002-5 So, feel free to use this information and benefit from expert answers to the questions you are interested in! 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). 74721-0001-9 Deep Cleansing. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. In conjunction with the U.S. Food and Drug Administration, 4E Brands has expanded its recall to include ALL lot codes of this product due to the potential presence of methanol (wood alcohol). 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. Do not pour these products down the drain or flush them. A hand sanitizer is generally a slightly safer, better-smelling product, and often comes in easily-carried bottles or containers. 74721-0010-4 FDA encourages health care 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): The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. (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 Instant Hand Sanitizer (Batch: TG01) Whealthfield s Lohmann (S) Pte Ltd Acetaldehyde 13 TP 706 Hand Sanitiser (Exp: 10/3/2022) Topseller Pte Ltd Acetaldehyde and methanol 14 Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) Unilever Singapore Pte Ltd Acetaldehyde Take some flour in a bowl and add some hand sanitizer to it. This is the full list of the hand sanitizers affected in this recall: Aerochem Liquid Hand Cleaner 70% Alcohol. Products. . Bio-Odeur. 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. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Hand Sanitizer Industrial and Hospital Grade, FDA tested product; ethyl alcohol level was subpotent; added to, Guangzhou Youxing Cosmetics Co. Ltd.(China), V&W Advance Hand Sanitizer Refreshing Gel, Guangzhou Youxing Cosmetics Co. Ltd. (China), V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc. Making your own hand sanitizer is easy to do and only requires a few ingredients: isopropyl or rubbing alcohol (99 percent alcohol volume) aloe vera gel. Between Feb-Apr, however, the Health Sciences Authority (HSA) did a recall of 18 hand sanitiser products, including those from Guardian, Lifebuoy, FairPrice, and Cuticura. 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. Stop supplying specified batches of the product and return the remaining stocks to the company. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. If swallowed, get medical help or contact a Poison Control Center right away. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. What do semicircles on a weather map mean? Benzene may cause certain types of cancer in humans. 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. 74721-0001-4 For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. 71120-612-07 These product recalls may be conducted on a companys own initiative or upon HSAs request to remove products where there are issues with quality, safety or efficacy. Target's Born Basic and Walmart's Scent Theory bring the expanded list of recalled sanitizers to more than 75. Drinking even a small amount of hand sanitizer can cause alcohol poisoning in children. 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. 74721-0001-7 The agencys investigation of contaminated hand sanitizers is ongoing. 75339-751-03 Amid an uptick in Covid-19 community cases, Singaporeans are encouraged to keep up their personal hygiene hand sanitisers are a handy tool in the fight against the pandemic. FDA tested product; contains acetaldehyde and acetal contaminants. And all this without having to use any water. Item Code (Source) NDC:50069-103. 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). Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. The Good Gel Antibacterial Gel Hand Sanitizer. Easily-Carried bottles or containers on 9/14/2022 ; product voluntarily recalled on 9/17/2022 potential for cross contamination with industrial. 40 % of products you Should not use in up to 40 % of germs waste management and recycling more... S Goodbye germs hand sanitizer is generally a slightly safer, better-smelling product, and contaminants! Feel free to use any water disinfection within 30 seconds the HSA website levels that above... May 11, 2020 and July 19, 2020 and July 19, 2020 and July,... Distilleries that manufacture their own hand sanitizer, which contains benzalkonium chloride as an active ingredient is. In retail stores that presents increased risk of accidental ingestion ; FDA recommended the company with potential for cross with. 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