Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. 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. 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 Target and Walmart issued recalls Tuesday for two potentially toxic hand sanitizers that were sold in stores and online. View more View less. Show More . 75821-001-04 cliger shop kimia . Boost your hand hygiene and immunity to keep fighting germs. The FDA has advised consumers not to use this hand sanitizer. 80969-010-02 Triclosan is a popular additive in many consumer products because it kills bacteria. Rub hands together, ensuring that the sanitizer goes all over front and back of the hands. 75339-751-05 Safe antimicrobial activity for surgical hand disinfection within 90 seconds. This makes Lifebuoy Immunity Boosting Hand Sanitizer your defense against germs without having to make a trip to the wash basin. 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. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 Our experts have done a research to get accurate and detailed answers for you. Singapore's Health Science Authority (HSA) has recalled 18 brands of hand sanitisers due to high levels of acetaldehyde and/or methanol According to the statement, the products were found to contain acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Inactive ingredients. This is the full list of the hand sanitizers affected in this recall: Aerochem Liquid Hand Cleaner 70% Alcohol. Route of Administration. . To use on hands, put a little sanitizer onto the palm. The Health Science Authority (HSA) has announced a wholesale-level recall of hand sanitisers. The dangers of drinking any hand sanitizer under any conditions. 74721-0010-2 74530-015-04 FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. Sophora Extract Product Information. Comprehensive antimicrobial activity for hygienic hand disinfection within 30 seconds. Consumers can easily identify which hand sanitizer products to avoid by using the following information: Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. Rub hands together until dry - Supervise children under 6 years of age when using this product to avoid swallowing. Tocopheryl acetate is low on the toxicity scale, but is often contaminated with hydroquinone, an extreme skin irritant. Odor neutralizing. Our Mission. 74721-0020-5 FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product. Avoid freezing and excessive heat above 40 (104). 80969-020-03 HAND SANITIZER SPRAY 100 ML / HANDSANITIZER SPRAY 100 ML. 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. Lifebuoy Antibacterial Hand Sanitizer has over 60% alcohol content and gives you instant germ protection. Call 9-1-1 if the person is unconscious or has trouble breathing. an essential oil, such as tea tree oil or lavender oil, or you can use lemon juice instead. 74530-013-03 The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use. Benzene may cause certain types of cancer in humans. Do not pour these products down the drain or flush them. 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. 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 issued, Alcohol Isopropilico Hand Sanitizer Limar, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021;product, Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to, BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to, MODESA Instant Hand Sanitizer Moisturizers and Vitamin E, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily, BLUMEN Advanced Instant Hand Sanitizer Lavender, BLUMEN Clear LEAR Advanced Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer Aloe, BLUMEN Clear Advanced Instant Hand Sanitizer Lavender, BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol, Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol, Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol, Blumen Antibacterial Fresh Citrus Hand Sanitizer, Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product, Assured Instant Hand Sanitizer (Vitamin E and Aloe), Assured Instant Hand Sanitizer (Aloe and Moisturizers), Assured Instant Hand Sanitizer Vitamin E and Aloe, Assured Instant Hand Sanitizer Aloe and Moisturizers, BLUMEN Instant Hand Sanitizer Fragrance Free, FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to, bio aaa Advance Hand Sanitizer 480 mL bottles, Product purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily, NuuxSan Instant Antibacterial Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily, Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers, Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E, Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to, Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to, DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages), SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada), Protz Real Protection Antibacterial Hand Sanitizer, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, 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, AltaioHand Sanitizing Wipes (80% Ethanol), 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;addedmanufacturerto, AltaioHand Sanitizing Wipes (70% Ethanol), Naturia Professional Green Hand Sanitizer, Essentials by Urban Secrets Hand Sanitizer, Essentials by Urban Secrets Advanced Hand Sanitizer, Botanicals Internacional SA de CV (Mexico), Alcohol Antiseptic 80% topical solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to, Total Pure Alcohol Based Hand Sanitizer Gel, Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi). 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). The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. Has been tested and is found to have microbial contamination. 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. What's the product for you Advanced Protection. And all this without having to use any water. Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. 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. The recalls were carried out on a Class 2 level, which is a wholesale level. Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol. Body wash ; Sanitizer ; Bar soap ; Hand wash . 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. 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). 74530-013-06 70% Alcohol Cleansing Gel Say Goodbye to Germs. 74530-015-05 Stop use and ask a doctor if irritation or rash occurs. 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. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. 74530-013-08, 74530-012-01 Antibacterial, antimicrobial hand sanitizer to help fight germs and bacteria. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. Not all recalls will lead to press releases. 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. Recall of hand sanitisers (Feb to April 2021) Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit. Sol-m Instant Hand Sanitizer : Alcohol: Gel: Topical: Sol-millennium Medical Inc: Human Otc Drug: 73720-0236: Sol-m Instant Hand Sanitizer : Alcohol: Gel: Topical: Sol-millennium Medical Inc: Human Otc Drug: 73720-0500: Sol-m Instant Hand Sanitizer : Alcohol: Gel: Topical: Sol-millennium Medical Inc: Human Otc Drug: 73720-1000: Sol-m Instant . Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. 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. Sterillium is the classic among the alcohol-based disinfectants for hygienic and surgical hand disinfection. Contact your local waste management and recycling center for more information on hazardous waste disposal. 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 unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. 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. 80969-010-06 Cleansing and sanitising on contact for better hygiene. 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. 74721-0002-3 Klar and Danver Instant Hand Sanitizer. Flavor Vapors, LLC, dba: Mob Liquid Labs 71120-112-11 Consumers who have products on thelist of hand sanitizerswith potential contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes. Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; the firm announced a voluntary recall on 10/18/2022. 74530-011-06 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. For questions, contact FDA:
[email protected]. Soothing. A asiafrenz High Supremacy Member 74721-0001-9 Grapefruit Extract, 74721-0001-1 74530-013-05 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. 71120-611-08 74530-012-06 Wat is the side effect.? 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. Uncategorized. 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. Lifebuoy Antibacterial Hand Sanitizers kill 99.9% bacteria and virus without water. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Bio-Odeur. 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. Cannot kill bacteria and germs? 74530-012-03 Products. FDA urges consumers not use certain hand sanitizer products. 74721-0001-6 While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal. 74721-0020-9, 71120-112-01 The Health Sciences Authority (HSA), on the other hand, issued a recall of 18 hand sanitizer products between February and April, including those from Guardian, Lifebuoy, FairPrice, and Cuticura. SPL UNCLASSIFIED SECTION. 75821-002-03. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. alcohol gel. Mint Oil Dettol Instant Hand Sanitizer. 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. An official website of the United States government, : Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. Lifebuoy Hand Sanitizer is the most convenient and instant way to hygienic hands. Fast and effective when there's no time for hand washing. 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. 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. Sophora Extract 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. The .gov means its official.Federal government websites often end in .gov or .mil. The site is secure. Protects against 99.9% of germs and is proven to be effective against Covid-19 Coronavirus. 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. 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. Modesa Instant Hand Sanitizer Moisturizers and Vitamin E. CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol. Before sharing sensitive information, make sure you're on a federal government site. 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel Gentle Protection. The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: Has been tested . The date of recall is from February to April 2021. Now, we have got the complete detailed explanation and answer for everyone, who is interested! 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. Purifying. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 74721-0002-7 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. 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. 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. 75821-001-03 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. 74721-0020-7 74530-011-03 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. 80969-020-04 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). The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue. 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. The new additions contain a. (But there is no need to be concerned if your children eat with or lick their hands after using hand sanitizer.). 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. . This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. 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. Assured Aloe. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 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. 74530-012-07 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. Hand sanitizer. [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. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA. 201 HENDERSON ROAD 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. Avoid freezing and excessive heat above 40 (104) LIFEBUOY HAND SANITIZER 75 PERCENT. Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 74721-0002-6 This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. With a range of hygiene products like sanitizers, wipes and hand wash - the brand ensures daily hygiene for the everyone - both outdoors and indoors. 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. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. 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. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 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. Apply enough Hand sanitiser gel on your palm. 74530-011-04 Individuals with compromised immune systems are at increased risk. 74721-0020-8 74721-0002-1 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. 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 . Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit. 71120-112-06 74530-013-07 When using this product keep out of eyes, ears, and mouth. Alcohol Free Disinfectant, Safe Cleaner Plus Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. #06-13/14 [emailprotected] When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. Welcome to Sharing Culture! 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. Lifebuoy Antibacterial Hand Sanitizer has over 60% alcohol content and gives you instant germ protection Lifebuoy Antibacterial Hand Sanitizer kills 99.9% bacteria and virus without water Lifebuoy Antibacterial Hand Sanitizer has Glycerine, it leaves your skin feeling moisturised Apply enough Hand sanitiser gel on your palm. Modesa Instant Hand Sanitizer Moisturizers and . The sanitizer dries quickly on skin, and keeps you and your family safe from germs. Lifebuoy Antibacterial Hand Sanitizer . 74721-0020-2 , FDA Safety Recalls, Presence in Breast Milk. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to thelistof hand sanitizers consumers should not use. 74530-015-02 74721-0001-8 containers resembling food pouches labeled with childrens characters, including Barbie, Hot Wheels, Paw Patrol, Minions, JoJo Siwa Dreamer and Trolls World Tour, Hand sanitizer products packaged in containers resembling food pouches commonly used for childrens applesauce and other pureed foods that present increased risk of accidental ingestion by children; FDA recommended the distributor recall on 9/21/2020; this advisory does not extend to Smart Care products in other types of packaging; product voluntarily, Lite n Foamy Lemon Blossom Hand Sanitizer, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020 and on 3/29/2021; FDA issued a, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020; FDA issued a, Private D Capital Group Corp., Human Choice LLC and RediBag USA Astrum LLC, Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to, SIREtizer Alcohol Antiseptic 80% Topical Solution Hand Sanitizer. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). [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. 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. Lifebuoy Antibacterial Hand Sanitizer kills 99.9% bacteria and virus without water. UNILEVER ASIA PRIVATE LIMITED. 75821-002-02 Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. Sanigen Gel Hand Refreshing Gel 600ml (all batches) 18. 74721-0001-7 (China). 74721-0010-9 Since the 1950s, it's been added to hand sanitizers, toothpastes, cookware, gardening tools, clothes, toys, furniture, and even some baby teething products. 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. Click on link below to viewthe list of affected products (Annex A): Recall of hand sanitisers (Feb to April 2021)_Annex A486 KB, Bringing personal medications into Singapore, Controlled drugs and psychotropic substances, Medicines quality and compliance monitoring, Registration guides for therapeutic products, Healthcare professional, Industry member, Cosmetic products, Advertisements and promotions of medicinal products, Free Sales Certificate and Export Certificate, Bringing personal medical devices into Singapore, COVID-19: Standards Resources for Essential Medical Devices, Listing of approvals and post-registration actions, Apply for retention, cancellation or transfer application, Fees and Turnaround time of Chinese Proprietary Medicines, Good Manufacturing Practice certification for cosmetic products, Tobacco retailer educational video and quiz, Register of Licensed CTGTP Importers, Wholesalers and Manufacturers, Regulations for bringing in personal medications, Guidance for suppliers of hand sanitisers, Good Distribution Practice for Medical Devices, Summary Reports of Benefit-Risk Assessment, GMP conformity assessment of overseas manufacturers, Preparations allowed as General Sale List, Good Manufacturing Practice and Good Distribution Practice Standards, Handling of Applications and Conduct of Inspections During COVID-19, Renew or cancel a retail pharmacy licence, Supply of registered therapeutic products through e-pharmacy, Product Quality Surveillance for therapeutic products, Apply for a Chinese Proprietary Medicine dealer's licence, Amend a Chinese Proprietary Medicine dealer's licence, Good Manufacturing Practice and Good Distribution Practice, Import for re-export of Chinese Proprietary Medicines, Amend licence to wholesale or manufacture controlled drugs, Fluorescence in situ hybridisation (FISH) probes IVD, Class D with a registrable drug in a secondary role full registration, Class D with registrable drug in secondary role abridged registration, Import for re-export of unregistered devices, Unregistered devices for non-clinical purposes, Registered medical devices on consignment basis, Unregistered devices requested by qualified practitioners, Unregistered devices requested by licensed PHMC, Import of unregistered medical devices for exhibition, Import of unregistered pre-owned devices from maintenance/repair, PSAR for Supply of Emergency Medical Devices, Import and supply of unregistered TP for patient's use, Import and supply of registered drug on consignment basis, Special consignment by a product registrant, Pandemic Special Access Route for Supply of Emergency TP, Special Access Route for Unauthorised COVID-19 Vaccines, Full evaluation route for MAV-1 application, Abridged evaluation route for MAV-1 application, Verification evaluation route for MAV-1 application, Good Manufacturing Practice certificate for local manufacturers, Good Distribution Practice certificate for local dealers, Nitrosamine impurities in medicines- List of medicines impacted, Apply for tobacco import and wholesale licence, Amend tobacco import and wholesale licence, Renew tobacco import and wholesale licence, Cancel tobacco import and wholesale licence, Import and supply of unregistered Class 2 CTGTP, Import and supply of CTGTP on consignment basis, Recall of hand sanitisers (Feb to April 2021)_Annex A, 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), Cool Day's Peppermint Instant Hand Sanitizer (all batches), 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). 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). The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. between May 11, 2020 and July 19, 2020. 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 . 18 hand sanitisers have been recalled. 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). What is simplifying rational expressions? FDAs investigation of methanol in certain hand sanitizers is ongoing. 75821-001-02 Topical Solution. 74721-0020-1 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). 74530-015-06, 74530-011-01 Drinking even a small amount of hand sanitizer can cause alcohol poisoning in children. Was lifebuoy hand sanitizer recalled? Directions. 74721-0002-8 The agency also included an additional denaturant formula in the temporary guidances. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Item Code (Source) NDC:50069-103. Take some flour in a bowl and add some hand sanitizer to it. We11 Daily Instant Hand Sanitiser All batches: Cool Day's Peppermint Instant Hand Sanitizer All batches: Walch Instant Hand Sanitizer TG01: TP 706 Hand Sanitiser Exp: 10/03/2022: Lifebuoy Instant Hand Sanitizer: OD13UL: FairPrice Hand Sanitiser Lavender 201251-001: germ-X Advanced Hand Sanitizer Original Scent All batches: Sanigen Gel . Notice to manufacturers and distributors: If you believe your products are no longer within the labeled expiry period, are no longer in distribution, or you otherwise have information that your products no longer warrant inclusion on this list, you should provide your reasoning and supporting information for FDAs consideration
[email protected]. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated,FDA urges consumers not to drink any of these products. Lifebuoy Hand Sanitizer Gel - 50mL NPN 80103793 BUY NOW 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. Grapefruit Extract, 74721-0010-1 71120-612-06 Which hand sanitizers are being recalled in Canada? 71120-117-02, 75821-001-01 The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. 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. Made in Korea. 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. 74721-0002-2 Yuri Hand Gel Green Tea Extract (all batches) The recall is classified under Class 2, which is for products with .
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