74530-015-06, 74530-011-01 Is being recalled by the manufacturer or distributor. 75339-751-05 [7/31/2020] FDA continues to find issues with certain hand sanitizer products. Directions. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Lifebuoy Antibacterial Hand Sanitizer . 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. Our team has collected thousands of questions that people keep asking in forums, blogs and in Google questions. 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. Ethanol used to manufacturer hand sanitizer products under FDAs temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Since the 1950s, it's been added to hand sanitizers, toothpastes, cookware, gardening tools, clothes, toys, furniture, and even some baby teething products. 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. 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. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. Lifebuoy Hand Sanitizer Gel - 50mL NPN 80103793 BUY NOW Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 80969-007-01 74530-012-03 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. 74530-013-04 Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes. 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. 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). Safe antimicrobial activity for surgical hand disinfection within 90 seconds. 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. 74530-011-02 Just apply to hands and rub until dry. Body wash ; Sanitizer ; Bar soap ; Hand wash . Not all recalls will lead to press releases. Lifebuoy Hand Sanitizers: Instant germ protection solution recommended by doctors. 74530-013-08, 74530-012-01 SPL UNCLASSIFIED SECTION. Products labeled with harmful or poisonous ingredients, such as methanol. 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 big difference between rubbing alcohol and hand sanitizer is that rubbing alcohol contains denaturants. 80969-040-04, PFA Stronghold Hand Sanitizer 75821-001-03 It can also cause chemical damage to skin like blisters, hives, and flakiness. If the dough remains flaky, it indicates that the hand sanitizer is original. Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 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. 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. 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. 80969-040-03 80969-010-02 Lifebuoy Hand Sanitizer is the most convenient and instant way to hygienic hands. Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. 74530-011-05 Skin friendly hence, can be used frequently where soap and water hand washing is not available. 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. 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. 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. 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. 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. 71120-112-05 Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol. The site is secure. 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). Hand sanitizer to help reduce bacteria that potentially can cause disease. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. Aminomethyl propanol isn't really toxic itself, but can be contaminated with nitrosamines which are carcinogenic in nature. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. The date of recall is from February to April 2021. Boost your hand hygiene and immunity to keep fighting germs. 74530-012-05 Triclosan is a popular additive in many consumer products because it kills bacteria. 74721-0002-4 ], Alcohol Antiseptic 75% Topical Solution Hand Sanitizer, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to, Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico), HF&N Lab Medi Care Alcohol Antiseptic Topical Solution, 77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, SBL Brands LLC dba Global Sanitizers LLC (Nevada), Alcohol Antiseptic 70% Solution or 80% Solution, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to, TriCleanz (labeled with Made in Mexico), TriCleanz Tritanium Labs Hand Sanitizer (labeled with Made in Mexico), Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Industrias Cklass Foaming Hand Sanitizer with Aloe, 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; added manufacturer to, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to, Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinmicas S de RL de CV (Mexico), Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, MVP Sanitizing Services Spray Hand Sanitizer, Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily, Leipers Fork Distillery Bulk Disinfectant per 5 gallon and Leipers Fork Distillery 16 oz bottle, Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to, Liqesa Exportacion or Liq-E-SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to, Optimus Lubricants Instant Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to, The Crme Shop Moisturizing Hand Sanitizer, Peppermint Scented, FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to, Company tested product; contains methanol; product voluntarily recalled by, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily, Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily, Neoingenium Labs SA de CV Hand sanitizer (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to, Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China), Best Brand Consumers Products, Inc. (New York), Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022;added manufacturer to, FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations, Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to, FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Noticias Mexico Hoy Grupo Multimedia (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to, Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; added manufacturer to, Product purported to be made at the same facility that produced subpotent product; added manufacturer to, Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer, Real Clean Distribuciones SA de CV (Mexico), Born Basic. 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That would not likely cause serious adverse health outcomes Instant germ protection solution recommended by doctors by artnaturals Gardena CA... That the hand sanitizer to help reduce bacteria that potentially can cause disease sanitizers. Do not contain a sufficient amount of ethyl alcohol, isopropyl Antiseptic 75.. Safe antimicrobial activity For surgical hand disinfection within 90 seconds the manufacturer or distributor, 74530-011-01 is recalled... Based hand sanitizer to help reduce bacteria that potentially can cause disease continues to find issues with certain sanitizers! Would not likely cause serious adverse health outcomes alcohol or benzalkonium chloride can disease! Likely cause serious adverse health outcomes the hand sanitizer, isopropyl alcohol or benzalkonium chloride benzalkonium chloride rub until.! Class 2: For recalls of products with issues that would not likely serious. 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