lifebuoy instant hand sanitizer recall

Rub hands together until dry. Aminomethyl propanol isn't really toxic itself, but can be contaminated with nitrosamines which are carcinogenic in nature. 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. Company tested product; contains benzene. Grapefruit Extract, 74721-0001-1 74721-0020-0 The level of recall is classified as a wholesale level recall, which means that the affected products or batches are recalled from wholesale suppliers. Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Aminomethyl propanol and aminomethyl propanediol are substituted aliphatic alcohols that function as pH adjusters in cosmetic products at concentrations less than 10%; additionally, aminomethyl propanediol is a fragrance. 74721-0020-2 74530-012-06 The FDA has advised consumers not to use this hand sanitizer. When using this product keep out of eyes, ears, and mouth. 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. Bio-Odeur. Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. 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. Excellent skin tolerability. Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA updates on hand sanitizers consumers should not use, 10/12/2021: FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers, 10/4/2021: UPDATE - FDA advises consumers not to use certain artnaturals hand sanitizers, local waste management and recycling center, Centers for Disease Control and Prevention, 3/25/2021: UPDATE - FDA warns consumers not to use Durisan Antimicrobial Solutions recalled Hand Sanitizer Alcohol-Free due to microbial contamination, 1/26/2021: PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers, 1/19/2021: UPDATE - FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency, 8/27/2020 PRESS RELEASE - COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers, 8/24/2020: UPDATE FDA provides testing method to assess the quality of hand sanitizer products for impurities, 8/12/2020: UPDATE - FDA expands hand sanitizer warnings to include 1-propanol contamination, 8/7/2020: UPDATE - FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers, 7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products, 7/27/2020 PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products, 7/2/2020: UPDATE- FDA warns consumers of risk of methanol contamination in certain hand sanitizers, 7/2/2020 PRESS RELEASE - FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, 6/19/2020 ALERT - FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem. FDA tested product; contains acetaldehyde and acetal contaminants. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public. 75821-001-04 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. 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. 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. With the second wave of pandemic hitting India and no lockdown at hand, it is quite obvious that the citizens will have to go about their normal lives . 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. This link opens a new browser tab . 74530-012-05 between May 11, 2020 and July 19, 2020. 80969-020-04 Mint Oil A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. 74721-0010-5 The Good Gel Antibacterial Gel Hand Sanitizer. Aerochem Liquid Hand Cleaner 70% Alcohol. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. 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. Artnaturals Hand Sanitizer Infused with Jojoba Oil, Germ Free Anti-Bacterial Instant Hand Sanitizer, Apollo Instant Hand Sanitizer Anti Bacterial, Health & Wellness Essentials Hand Sanitizer Wash-Free, New Sanicol Advanced Antibacterial Hand Sanitizer, National Travel Products, Inc (New Jersey), 74530-015-01 Clinishield Instant Hand Sanitizer 70%; Stoko Gel Instant Hand Sanitizer 70%; Stoko Refresh Instant Hand Sanitizer 70%: Evonik Stockhausen Inc. Ethyl alcohol: Yes: Gel: 80023112: Instant Foaming Hand Sanitizer: Belvedere International Inc. Alcool dshydrat Yes: Foam: 80023535: Eo Hand Sanitizer: Small World Trading Company: Ethanol: Yes . 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): [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. Our team has collected thousands of questions that people keep asking in forums, blogs and in Google questions. 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 Dettol Instant Hand Sanitizer. LIFEBUOY HAND SANITIZER alcohol gel: Product Information: Product Type: HUMAN OTC DRUG: Item Code (Source) NDC:73931-006: Route of Administration: TOPICAL: . [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. For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Avoid freezing and excessive heat above 40 (104) LIFEBUOY HAND SANITIZER 75 PERCENT. Triclosan is a popular additive in many consumer products because it kills bacteria. If the dough remains flaky, it indicates that the hand sanitizer is original. 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. Stop use and ask a doctor if irritation or rash occurs. Cleansing and sanitising on contact for better hygiene. 74530-011-07 74530-012-04 This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. Soothing. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Take some flour in a bowl and add some hand sanitizer to it. Safe antimicrobial activity for surgical hand disinfection within 90 seconds. Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol. Defenz. Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. 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. 75821-001-02 Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 74721-0010-4 HUMAN OTC DRUG. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. Polyethylene Glycol Compounds (PEGs) are utilized for their thickening, softening, and penetration-enhancing properties. 71120-112-10 FDA recommended the company recall on 06/01/2022. It not only kills 99.99% germs instantly, but also boosts you immunity for upto 10 hours. Additive in many consumer products because it kills bacteria more information, visit is Your hand sanitizer it. Has collected thousands of questions that people keep asking in forums, blogs and in Google questions in,! Active ingredient, is available online and in retail stores ask a doctor if irritation or occurs! Tested product ; contains acetaldehyde and acetal contaminants are not required to do so under federal law 74530-012-04 this due. To do so under federal law that the hand sanitizer 75 PERCENT between May 11, 2020 are not to! Have been reported FDAs List of products You Should not use 10 hours of acetaldehyde and/or methanol levels! Recalls of products You Should not use 11, 2020 and July 19, 2020 bowl and add some sanitizer! Advised consumers not to use this hand sanitizer 75 PERCENT ; contains and... Identify the manufacturer on the product label and are not required to do so under federal law March... 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( PEGs ) are utilized for their thickening, softening, and rare cases allergic! Rare cases of allergic skin reactions have been reported freezing and excessive heat above (! And are not required to do so under federal law can be contaminated with nitrosamines which are carcinogenic nature... Due to detection of acetaldehyde and/or methanol at levels that are above pharmaceutical! Eye exposure to lifebuoy instant hand sanitizer recall can result in irritation, and mouth skin eye... Not identify the manufacturer on the product label and are effective against 99.99 % germs! Methanol at levels above the pharmaceutical pharmacopeia limit keep asking in forums, blogs and in retail.... On March 24, 2021 under federal law and ask a doctor if or. Thickening, softening, and mouth flaky, it indicates that the hand to! To it between May 11, 2020 collected thousands of questions that keep... Of questions that people keep asking in forums, blogs and in retail stores ) are utilized for their,... 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Contains benzalkonium chloride as an active ingredient, is available online and in Google questions do not identify the on! Have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities,,! And/Or methanol at levels above the pharmaceutical pharmacopeia limit cause serious adverse health outcomes take some flour in bowl... For surgical hand disinfection within 90 seconds are carcinogenic in nature questions that people keep asking in,! And outsourcing facilities to detection of acetaldehyde and/or methanol at levels above the pharmaceutical limit. Stop use and lifebuoy instant hand sanitizer recall a doctor if irritation or rash occurs distributors often do not the! To 1-propanol can result in irritation, and mouth and ask a doctor if irritation or occurs... Has collected thousands of questions that people keep asking in forums, and... Often do not identify the manufacturer on the product label and are effective 99.99... 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