71120-117-02, 75821-001-01 74721-0002-8 FDA has not evaluated whether this product complies. Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. What do semicircles on a weather map mean? Godrej Protekt Hand Sanitizer. 74530-013-07 Avoid freezing and excessive heat above 40 (104). Defenz. Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. 71120-112-08 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Avoid freezing and excessive heat above 40 (104) LIFEBUOY HAND SANITIZER 75 PERCENT. 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 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. The recalls were carried out on a Class 2 level, which is a wholesale level. Benzene may cause certain types of cancer in humans. Yuri Hand Gel Green Tea Extract (all batches) The recall is classified under Class 2, which is for products with . 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. When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. 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. FairPrice Hand Sanitiser Lavender (Batch: 201251-001) 16. germ-X Advanced Hand Sanitizer Original Scent (all batches) 17. 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. Sanigen Gel Hand Refreshing Gel 600ml (all batches) 18. 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. 80969-040-03 FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Set id: 6f83fed4-5dd2-4a48-8ec7-749b01a328f7, 50 mL in 1 BOTTLE; Type 0: Not a Combination Product, 500 mL in 1 BOTTLE; Type 0: Not a Combination Product, 50 mL in 1 TUBE; Type 0: Not a Combination Product, Place enough product on hands to cover all surfaces. Soothing. 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. Unibeleza Industria E Comercio De 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. The Health Sciences Authority (HSA) of Singapore has recently recalled 18 sanitizers, this includes products from Lifebuoy, Walch, Guardian and more. Supervise children under 6 years of age when using this product to avoid swallowing. Each pack contains 20 bottles of 500ml. Tocopheryl acetate is low on the toxicity scale, but is often contaminated with hydroquinone, an extreme skin irritant. Lifebuoy Hand Sanitizers: Instant germ protection solution recommended by doctors. Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. 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. 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. 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. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 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). 74530-011-05 Lifebuoy Hand Sanitizer - 75% Ethyl Alcohol. The FDA has advised consumers not to use this hand sanitizer. 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. This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. This makes rubbing alcohol unpalatable for human consumption. Flavor Vapors, LLC, dba: Mob Liquid Labs This link opens a new browser tab . 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. 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. Made in Korea. 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. Restaurant Supplies Hand Sanitizer, FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Yacana Alcohol Antiseptic 70% Topical Solution, FDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily, Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 8/12/2020; product voluntarily, Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/12/2020; product voluntarily, Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China), FDA tested product; contains methanol; product voluntarily recalled by, Guangdong Kemei Pharmaceutical Technology Co. Ltd, KLEAN KARE Hand Sanitizer Industrial and Hospital Grade, Essentials, M.D. Grapefruit Extract, 74721-0010-1 Individuals with compromised immune systems are at increased risk. Now, we have got the complete detailed explanation and answer for everyone, who is interested! 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. Filter products an essential oil, such as tea tree oil or lavender oil, or you can use lemon juice instead. UNILEVER ASIA PRIVATE LIMITED. 74721-0002-9, 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 7/12/2022, Safe Cleaner K FDA urges consumers not use certain hand sanitizer products. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: Has been tested . 74721-0020-8 74721-0010-6 Skin friendly hence, can be used frequently where soap and water hand washing is not available. Mint Oil 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. Modesa Instant Hand Sanitizer Moisturizers and Vitamin E. CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol. 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). 74721-0010-8 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel SPL UNCLASSIFIED SECTION. Excellent skin tolerability. Topical Solution. 74721-0001-0 Need help now? The agency will provide additional information as it becomes available. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. FDAs investigation of methanol in certain hand sanitizers is ongoing. Products. Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 74530-013-03 (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 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. . 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