Hand sanitizer to help reduce bacteria that potentially can cause disease. [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. HUMAN OTC DRUG. 74721-0020-9, 71120-112-01 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. 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. 74530-011-05 About Lifebuoy. The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. 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. 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. 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. 74530-011-08, 74530-013-01 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. LIFEBUOY HAND SANITIZER alcohol gel: Product Information: Product Type: HUMAN OTC DRUG: Item Code (Source) NDC:73931-006: Route of Administration: TOPICAL: . 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). 74530-015-03 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. 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. 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. 74721-0020-5 Avoid freezing and excessive heat above 40 (104). Target and Walmart issued recalls Tuesday for two potentially toxic hand sanitizers that were sold in stores and online. 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. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. FDA has not evaluated whether this product complies. 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. 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. Aerochem Liquid Hand Cleaner 70% Alcohol. Consumer and health care professional safety is a top priority for FDA, and an important part of FDAs mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply. Soothing. 70% Alcohol Cleansing Gel Say Goodbye to Germs. 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). Lifebuoy Instant Sanitizer contains 70% alcohol. Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit. Stop supplying specified batches of the product and return the remaining stocks to the company. Yuri Hand Gel Green Tea Extract (all batches) The recall is classified under Class 2, which is for products with . 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. The FDA has advised consumers not to use this hand sanitizer. Made in Korea. 74721-0020-0 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. 71120-612-06 The Health Science Authority (HSA) has announced a wholesale-level recall of hand sanitisers. FDA recommended the company recall on 06/01/2022. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. Not all recalls will lead to press releases. 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): [1/19/2021] Today, FDA issued a guidance outlining the agencys policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products. Sophora Extract Do not pour these products down the drain or flush them. 74721-0001-2 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. 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. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. Mint Oil Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 74721-0010-5 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. A asiafrenz High Supremacy Member Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Small doses of triethanolamine are approved, but too much will be harmful. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. 80969-008-01, 80969-010-01 Instant Sanitizer is the ultimate convenience, one spray easily covers the entire hand. Rub hands together until dry - Supervise children under 6 years of age when using this product to avoid swallowing. 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. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. Lifebuoy Hand Sanitizers: Instant germ protection solution recommended by doctors. 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. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. Each pack contains 20 bottles of 500ml. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. 75 Hand Sanitizers Now on FDA Recall List. 71120-611-07 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. (China). Lifebuoy Antibacterial Hand Sanitizers kill 99.9% bacteria and virus without water. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public. 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 Lifebuoy Hand Sanitizer Gel - 50mL NPN 80103793 BUY NOW Bio-Odeur. LIFEBUOY HAND SANITIZER75 PERCENT- alcoholgel 74530-012-03 74530-013-03 This is due to the detection of acetaldehyde and/or methanol at levels that are above the pharmaceutical pharmacopeia limit. Deep Cleansing. Comprehensive antimicrobial activity for hygienic hand disinfection within 30 seconds. Klar and Danver Instant Hand Sanitizer. This is your one-stop encyclopedia that has numerous frequently asked questions answered. 74721-0002-1 74721-0001-5 FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product. The Good Gel Antibacterial Gel Hand Sanitizer. Safe antimicrobial activity for surgical hand disinfection within 90 seconds. Acetal can irritate the upper respiratory tract, eyes, and skin. In case of contact, rinse eyes thoroughly with water. 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). Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. Sophora Extract 74721-0002-3 74721-0001-8 This is a question our experts keep getting from time to time. FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. Rub hands together, ensuring that the sanitizer goes all over front and back of the hands. Grapefruit Extract, 74721-0010-1 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. Our team has collected thousands of questions that people keep asking in forums, blogs and in Google questions. . Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. FDA is not aware of any adverse events related to Durisans hand sanitizer products. Target's Born Basic and Walmart's Scent Theory bring the expanded list of recalled sanitizers to more than 75. FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022. FDA will consider revising the list as appropriate. 80969-020-04 Antibacterial, antimicrobial hand sanitizer to help fight germs and bacteria. 75821-001-03 Dettol Instant Hand Sanitizer. 75339-751-03 Last Update: October 15, 2022 . 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. Tocopheryl acetate is low on the toxicity scale, but is often contaminated with hydroquinone, an extreme skin irritant. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Triclosan is a popular additive in many consumer products because it kills bacteria. 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). 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