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 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. The agency also included an additional denaturant formula in the temporary guidances. HUMAN OTC DRUG. FDA recommended the company recall all drug products on 12/12/2022. 74530-013-07 (Nevada), Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022, Salon Technologies International The world health organisation recommends to use an alcohol based hand sanitizer when out of home to prevent the spread of bacteria and virus. This is different from a consumer level recall where the products or batches are recalled from patients, consumers, wholesale suppliers, retail suppliers, hospitals, clinics, and pharmacies, or a retail level recall, where products or batches are recalled fromretail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers. Skin friendly hence, can be used frequently where soap and water hand washing is not available. Just apply to hands and rub until dry. 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. Company tested product; contains benzene. Apply enough Hand sanitiser gel on your palm. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. Soothing. 80969-010-06 Contact your local waste management and recycling center for more information on hazardous waste disposal. Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. 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 . 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. Product Information. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. 74530-011-03 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 80969-010-02 74721-0002-7 Do not pour these products down the drain or flush them. 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 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. 74721-0020-1 Flavor Vapors, LLC, dba: Mob Liquid Labs FairPrice Hand Sanitiser Lavender (Batch: 201251-001) 16. germ-X Advanced Hand Sanitizer Original Scent (all batches) 17. 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 has been unable to contact the manufacturer or the distributor to recommend the company recall its product. The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: Has been tested . Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. Our experts have done a research to get accurate and detailed answers for you. 74530-012-04 Cleansing and sanitising on contact for better hygiene. Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. 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. 80969-007-01 Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Benzene may cause certain types of cancer in humans. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. Dettol Instant Hand Sanitizer. Apply enough Hand sanitiser gel on your palm. 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. 80969-010-07 These product recalls may be conducted on a companys own initiative or upon HSAs request to remove products where there are issues with quality, safety or efficacy. 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. 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. Purifying. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. The level of recall is classified as a wholesale level recall, which means that the affected products or batches are recalled from wholesale suppliers. 74721-0002-8 71120-112-08 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). And all this without having to use any water. 75821-001-04 . 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. Our team has collected thousands of questions that people keep asking in forums, blogs and in Google questions. 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. Target's Born Basic and Walmart's Scent Theory bring the expanded list of recalled sanitizers to more than 75. FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to, Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to, Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution, Smart Care hand sanitizer packaged in 0.84 fl oz. 75339-751-02 74721-0002-2 [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. 74721-0001-0 A lot has happened since the COVID-19 global pandemic reached the shores of America in 2020. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. 255 FDA-Recalled Hand Sanitizers to Beware of as COVID-19 Continues Spreading. 74721-0010-8 Blumen products. 75821-001-03 Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. 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. 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. 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. What's the product for you Advanced Protection. 75821-002-02 Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) 15. These may be signs of a serious condition. 74530-011-06 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. 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. 80969-040-04, PFA Stronghold Hand Sanitizer [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. [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. 71120-112-10 Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. 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. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 74721-0020-9, 71120-112-01 Not all recalls will lead to press releases. FDA issued a, Yara Elena de La Garza Perez Nieto (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added manufacturer to, Product labeled to be edible alcohol; added manufacturer to. Is being recalled by the manufacturer or distributor. 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 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. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 74721-0001-2 Body wash ; Sanitizer ; Bar soap ; Hand wash . Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. 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. 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. Learn more at poisonhelp.hrsa.gov/. 75339-751-03 Guangzhou Minghui Cosmetics Co. Ltd. (China), Product purported to be made at the same facility that produced subpotent ethyl alcohol product;added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued awarning letteron 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021, Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022. Lifebuoy Hand Sanitizer - 75% Ethyl Alcohol. 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. Lifebuoy Hand Sanitizer is the most convenient and instant way to hygienic hands. Health & Hygiene. Gigi's Goodbye Germs Hand Sanitizer. LIFEBUOY HAND SANITIZER75 PERCENT- alcoholgel 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.. , FDA Safety Recalls, Presence in Breast Milk. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 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. Triclosan is a popular additive in many consumer products because it kills bacteria. Fast and effective when there's no time for hand washing. 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. 74530-013-06 Odor neutralizing. 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. 71120-612-06 71120-112-05 Sterillium is the classic among the alcohol-based disinfectants for hygienic and surgical hand disinfection. The Health Sciences Authority (HSA) of Singapore has recently recalled 18 sanitizers, this includes products from Lifebuoy, Walch, Guardian and more. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Modesa Instant Hand Sanitizer Moisturizers and Vitamin E. Hello Kitty by Sanrio Hand Sanitizer. 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. Show More . 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. Rub hands together, ensuring that the sanitizer goes all over front and back of the hands. 74721-0001-8 75821-002-03. 74721-0010-7 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). To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. It can also cause chemical damage to skin like blisters, hives, and flakiness. Safe antimicrobial activity for surgical hand disinfection within 90 seconds. an essential oil, such as tea tree oil or lavender oil, or you can use lemon juice instead. 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. It not only kills 99.99% germs instantly, but also boosts you immunity for upto 10 hours. Comprehensive antimicrobial activity for hygienic hand disinfection within 30 seconds. A asiafrenz High Supremacy Member FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. FDA tested product; contains acetaldehyde and acetal contaminants. 74530-011-05 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. 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. Assured Aloe. This makes Lifebuoy Immunity Boosting Hand Sanitizer your defense against germs without having to make a trip to the wash basin. (But there is no need to be concerned if your children eat with or lick their hands after using hand sanitizer.). by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. Bio-Odeur. FDA recommended the company recall on 06/01/2022. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 The new additions contain a. For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. Medline Plus . If you can knead the dough easily just like you do with water, it means the hand sanitizer is fake. Brands include Lifebuoy, Guardian, Walch, and Cath Kidston By Kristen Juliet Soh 1 May, 2021 The Health Science Authority (HSA) has announced a wholesale-level recall of hand sanitisers. 80969-020-03 Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. 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). 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. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. 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. They are found in a wide range of consumer products including hand sanitizers. Instantly, but also boosts you immunity for upto 10 hours tested product ; contains acetaldehyde and contaminants. Goodbye germs hand Sanitizer, which contains benzalkonium chloride as an active ingredient, available. Most convenient and Instant way to hygienic hands additionally, FDA reminds consumers that no drugs, including sanitizers... Additionally, FDA reminds consumers that no drugs, including hand sanitizers to more than 75 for. 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