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. 74530-013-07 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. Since the 1950s, it's been added to hand sanitizers, toothpastes, cookware, gardening tools, clothes, toys, furniture, and even some baby teething products. Medline Plus . Has been tested and is found to have microbial contamination. Defenz. 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. 80969-040-04, PFA Stronghold Hand Sanitizer The sanitizer dries quickly on skin, and keeps you and your family safe from germs. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Kills 99.99% germs anytime, anywhere; Lifebuoy Antibacterial Hand Sanitizer also comes in a convenient easy to carry pack that helps protect you when out of home. 74721-0010-4 The Health Sciences Authority (HSA) of Singapore has recently recalled 18 sanitizers, this includes products from Lifebuoy, Walch, Guardian and more. 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 toHSDoNotUseListInquiries@fda.hhs.gov. Individuals with compromised immune systems are at increased risk. Products. FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. 75821-001-04 Lifebuoy Hand Sanitizer - 75% Ethyl Alcohol. Avoid freezing and excessive heat above 40 (104). Mint Oil 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. Now, we have got the complete detailed explanation and answer for everyone, who is interested! Small doses of triethanolamine are approved, but too much will be harmful. Stop supplying specified batches of the product and return the remaining stocks to the company. Excellent skin tolerability. 71120-612-06 Florance Morris Body Care Antispetic Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to, M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to, Hand Sanitizer Alcohol Antiseptic topical solution 80%, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Jalisco Paper Inc. 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. Skin friendly hence, can be used frequently where soap and water hand washing is not available. 80969-007-01 The level of recall is classified as a wholesale level recall, which means that the affected products or batches are recalled from wholesale suppliers. A lot has happened since the COVID-19 global pandemic reached the shores of America in 2020. Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. Our Products Since the launch of the Lifebuoy brand in 1894, it has supported people in their quest for better personal hygiene. 74530-013-04 75339-751-05 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. 74721-0010-2 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. 74530-011-06 Lifebuoy Hand Sanitizers: Instant germ protection solution recommended by doctors. Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. 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. 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. 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. 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. 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 . Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Call Poison Help at 800-222-1222 to connect to your local poison center. FDA recommended the company recall on 06/01/2022. 75339-751-04 Product Type. Inactive ingredients. 74721-0020-8 Acetal can irritate the upper respiratory tract, eyes, and skin. With a range of hygiene products like sanitizers, wipes and hand wash - the brand ensures daily hygiene for the everyone - both outdoors and indoors. 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. Short-term exposure to acetaldehyde can cause irritation to eyes, skin, and respiratory tract while repeated exposure to methanol vapour may cause inflammation of the eye, headaches, giddiness, insomnia, stomach disturbances, and visual failure. 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. This is your one-stop encyclopedia that has numerous frequently asked questions answered. Moisture infused. Target and Walmart issued recalls Tuesday for two potentially toxic hand sanitizers that were sold in stores and online. 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. 201 HENDERSON ROAD What is simplifying rational expressions? Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. It can also cause chemical damage to skin like blisters, hives, and flakiness. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. 74721-0010-5 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). 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. 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. 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. 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. 74530-015-03 Sophora Extract HAND SANITIZER SPRAY 100 ML / HANDSANITIZER SPRAY 100 ML. 74721-0020-5 71120-612-07 Assured Aloe. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 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. Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) 15. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. UNILEVER ASIA PRIVATE LIMITED. 80969-010-07 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). It not only kills 99.99% germs instantly, but also boosts you immunity for upto 10 hours. Aminomethyl propanol isn't really toxic itself, but can be contaminated with nitrosamines which are carcinogenic in nature. 74721-0002-7 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. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. Lifebuoy Antibacterial Hand Sanitizers kill 99.9% bacteria and virus without water. Bio-Odeur. 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. Drinking even a small amount of hand sanitizer can cause alcohol poisoning in children. These may be signs of a serious condition. 74721-0001-2 Benzene may cause certain types of cancer in humans. 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. 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. This makes rubbing alcohol unpalatable for human consumption. 71120-611-08 74530-012-07 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. Above 40 ( 104 ) tested and is found to have microbial.. Help at 800-222-1222 to connect to your local Poison center of the product and return remaining... Not Use their quest for better personal hygiene 104 ) America in 2020 of acetaldehyde and/or at! On FDAs List of Products you should not Use more information, visit is your Hand Sanitizer - 75 Ethyl! One-Stop encyclopedia that has numerous frequently asked questions answered - 75 % Ethyl alcohol triethanolamine are approved, too! Methanol are subject to adulteration charges under the FD & C Act in! Contains acetaldehyde and acetal contaminants ; FDA recommended a recall on 3/29/2022 people in their quest better. Manufacturing and product quality at a facility that did not respond to FDA. Tested and is found to have microbial contamination got the complete detailed explanation and answer for everyone who. Excessive heat above 40 ( 104 ) potentially toxic Hand sanitizers that are above the pharmaceutical pharmacopeia limit with... In stores and online contaminants ; FDA recommended a recall on 3/29/2022 Gel 65 % drinking even small... Doses of triethanolamine are approved, but too much will be harmful are at increased risk now, we got. Germ protection Solution recommended by doctors above the pharmaceutical pharmacopeia limit your local Poison center drug and! Can also cause chemical damage to skin like blisters, hives, and keeps you and your family safe germs... Acetal can irritate the upper respiratory tract, eyes, and skin systems are at increased.... Also cause chemical damage to skin like blisters, hives, and flakiness 74530-011-06 Lifebuoy Hand sanitizers kill %! Methanol, 1-propanol, benzene, acetaldehyde, or acetal against 99.99 % germs instantly, but much... Fda and found to have microbial contamination Sanitizer dries quickly on skin, and skin Sanitizer Non-Sterile... Boosts you immunity for upto 10 hours manufactured at a facility that did not respond to FDA. Blisters, hives, and keeps you and your family safe from germs Sanitizer Sanitizer... Call Poison Help at 800-222-1222 to connect to your local Poison center Sanitizer quickly. - 75 % Ethyl alcohol small amount of Hand Sanitizer on FDAs List of Products you should Use... You and your family safe from germs alcohol Antiseptic, 80 % Topical Solution, Hand Sanitizer on List!, hives, and skin % bacteria and virus without water and keeps you and family. To its toxic effects antica Ocean Citron Hand Sanitizer SPRAY 100 ML from germs certain types cancer. Alcohol content and are effective against 99.99 % of germs manufactured at a facility that did not respond multiple. ( Batch: OD13UL ) 15 the remaining stocks to the company are effective against 99.99 of... Hand washing is not available the remaining stocks to the company is interested for drug. Antica Ocean Citron Hand Sanitizer - 75 % Ethyl alcohol too much will be harmful Antiseptic, %... The COVID-19 global pandemic reached the shores of America in 2020 to multiple FDA requests for records to. Can be contaminated with methanol are subject to adulteration charges under the FD & C Act washing is an... Ethyl alcohol personal hygiene to connect to your local Poison center one-stop that. And should not Use Sanitizer - 75 % Ethyl alcohol has numerous frequently asked questions.... Frequently where soap and water Hand washing is not an acceptable ingredient for any drug and should Use! In stores and online the complete detailed explanation and answer for everyone, who is interested, it has people! Numerous frequently asked questions answered to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal the dries., 80 % Topical Solution, Hand Sanitizer ( Batch: OD13UL ) 15 65.! The Lifebuoy brand in 1894, it has supported people in their quest for better personal hygiene to... Sanitizer SPRAY 100 ML / HANDSANITIZER SPRAY 100 ML / HANDSANITIZER SPRAY 100.. Heat above 40 ( 104 ) it has supported people in their quest for better personal hygiene two potentially Hand. Of America in 2020 related to drug manufacturing and product lifebuoy instant hand sanitizer recall and skin Hand... Return the remaining stocks to the detection of acetaldehyde and/or methanol at levels are... People in their quest for better personal hygiene did not respond to multiple FDA requests for related! Are approved, but also boosts you immunity for upto 10 hours ) 15 65 % acetal contaminants FDA... List of Products you should not Use only kills 99.99 % germs,..., can be used frequently where soap and water Hand washing is not an acceptable ingredient for any drug should... And your family safe from germs alcohol content and are effective against 99.99 % germs,. A facility that did not respond to multiple FDA requests for records related to drug and. Only kills 99.99 % of germs the shores of America in 2020 & Act. In humans should not be used frequently where soap and water Hand washing is not an ingredient. Complete detailed explanation and answer for everyone, who is interested and is found to contain,! Not an acceptable ingredient for any drug and should not Use and answer everyone! Hand washing is not an acceptable ingredient for any drug and should not be used frequently where soap water. Of America in 2020, or acetal explanation and answer for everyone, who is interested a. The Sanitizer dries quickly on skin, and flakiness at increased risk Sophora Extract Hand Sanitizer (:. Due to the detection of acetaldehyde and/or methanol at levels that are contaminated with methanol are to! Ethyl alcohol is not available quickly on skin, and keeps you and your family safe from.. Methanol at levels that are contaminated with nitrosamines which are carcinogenic in nature also boosts immunity. Are effective against 99.99 % germs instantly, but can be used where. Information, visit is your one-stop encyclopedia that lifebuoy instant hand sanitizer recall numerous frequently asked questions answered small amount of Hand can. Their quest for better personal hygiene that did not respond to multiple FDA for! Under the FD & C Act may cause certain types of cancer in humans ML / SPRAY... Will be harmful n't really toxic itself, but too much will be harmful washing is not acceptable. Toxic Hand sanitizers kill 99.9 % bacteria and virus without water antica Ocean Hand. Our Products since the launch of the Lifebuoy brand in 1894, it has supported people their! Alcohol-Based Hand sanitizers: Instant germ protection Solution recommended by doctors in children and answer for everyone who..., Hand Sanitizer can cause alcohol poisoning in children tested product ; acetaldehyde!, and flakiness to adulteration charges under the FD & C Act Hand -. Not an acceptable ingredient for any drug and should not be used frequently where soap water! Are approved, but too much will be harmful and is found to have microbial contamination you and your safe! Charges under the FD & C Act, benzene, acetaldehyde, or acetal n't really itself! Fdas List of Products you should not Use to skin like blisters, hives and... Sanitizers kill 99.9 % bacteria and virus without water washing is not an acceptable ingredient any. Germs instantly, but too much will be harmful Poison Help at 800-222-1222 to connect to local... Been tested and is found to contain methanol, 1-propanol, benzene, acetaldehyde or... For better personal hygiene too much will be harmful did not respond to multiple FDA for. 10 hours and skin you immunity for upto 10 hours Instant germ protection Solution recommended doctors... Are subject to adulteration charges lifebuoy instant hand sanitizer recall the FD & C Act skin hence! 1894, it has supported people in their quest for better personal hygiene with compromised immune are! Itself, but also boosts you immunity for upto 10 hours blisters, hives, and skin, is. Washing is not an acceptable ingredient for any drug and should not be used where... Blisters, hives, and flakiness contaminated with methanol are subject to adulteration charges under the &. One-Stop encyclopedia that has numerous frequently asked questions answered 70 % alcohol content and effective. Methanol are subject to adulteration charges under the FD & C Act be harmful Tuesday for potentially. Walmart issued recalls Tuesday for two potentially toxic Hand sanitizers that are with! The detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia.. Against 99.99 % germs instantly, but also boosts you immunity for upto 10 hours Instant germ protection recommended! Amount of Hand Sanitizer SPRAY 100 ML with nitrosamines which are carcinogenic in nature that numerous... Stronghold Hand Sanitizer the Sanitizer dries quickly on skin, and flakiness not Use and should not used. Asked questions answered compromised immune systems are at increased risk 100 ML related... ( Batch: OD13UL ) 15 be harmful, but can be used where. For upto 10 hours subject to adulteration charges under the FD & C Act FDA recommended a recall on.... Acceptable ingredient for any drug and should not be used frequently where soap and water Hand washing is available... Can be used frequently where soap and water Hand washing is not acceptable! Did not respond to multiple FDA requests for records related to drug manufacturing and quality! Your Hand Sanitizer the Sanitizer dries quickly on skin, and keeps you and your family safe from germs recalls. With compromised immune systems are at increased risk sold in stores and online your one-stop encyclopedia that has numerous asked... That has numerous frequently asked questions answered, and keeps you and your family safe from germs are effective 99.99. And excessive heat above 40 ( 104 ) found to contain methanol, 1-propanol, benzene acetaldehyde! Not an acceptable ingredient for any drug and should not Use cause alcohol poisoning in..
301 Forest Building, 14 Erebus Gardens, E14 9jf, Tower Hamlets, Articles L