74721-0001-5 Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; the firm announced a voluntary recall on 10/18/2022. 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. Bio-Odeur. 74530-015-06, 74530-011-01 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 . What do semicircles on a weather map mean? FDAs investigation of methanol in certain hand sanitizers is ongoing. 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. FDA tested product; contains acetaldehyde and acetal contaminants. 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. 74721-0002-7 80969-010-07 To the campus community: The U.S. Food and Drug Administration (FDA) recently recommended a recall of Blumen clear advanced hand sanitizer with 70% alcohol due to the product testing positive for methanol contamination. Apply enough Hand sanitiser gel on your palm. 74721-0010-4 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. 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. 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. 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. Cleansing and sanitising on contact for better hygiene. FDA recommended the company recall on 9/20/2021;product voluntarily recalled on 9/21/2021, SBL Brands LLC dba Global Sanitizers, LLC (Nevada), Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA issued a, Scentsational Soaps and Candles Inc. (Florida), Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution, Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily, Fresh Lemon Citron Frais Scented Hand Sanitizer, SS Black and White Collection and Photo Real Collection: Coconut Breeze; Eucalyptus & Mint; Lavender & Herbs; Lemon Zest; Tangerine & Guava, Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 1/20/2022; product voluntarily recalled on 1/28/2022. FairPrice Hand Sanitiser Lavender (Batch: 201251-001) 16. germ-X Advanced Hand Sanitizer Original Scent (all batches) 17. Zorin Pharmaceutical Technology 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 10/12/2022, Biotipo Pharma Medical Sanitizing Hand Wipes, PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil. 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. Item Code (Source) NDC:50069-103. Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) 15. 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. . Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. Uncategorized. Antibacterial, antimicrobial hand sanitizer to help fight germs and bacteria. 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. Lifebuoy Hand Sanitizer is the most convenient and instant way to hygienic hands. This makes Lifebuoy Immunity Boosting Hand Sanitizer your defense against germs without having to make a trip to the wash basin. Lifebuoy Antibacterial Hand Sanitizer kills 99.9% bacteria and virus without water. 74721-0010-6 Lifebuoy Antibacterial Hand Sanitizer . Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Wat is the side effect.? FDA urges consumers not use certain hand sanitizer products. 74721-0020-6 71120-112-05 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. 74721-0001-9 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. 70% Alcohol Cleansing Gel Say Goodbye to Germs. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. LIFEBUOY HAND SANITIZER alcohol gel: Product Information: Product Type: HUMAN OTC DRUG: Item Code (Source) NDC:73931-006: Route of Administration: TOPICAL: . For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Lifebuoy Antibacterial Hand Sanitizers kill 99.9% bacteria and virus without water. The agency will provide additional information as it becomes available. Rp6.000. Company tested product; contains benzene. Triclosan is a popular additive in many consumer products because it kills bacteria. The level of recall is classified as a wholesale level recall, which means that the affected products or batches are recalled from wholesale suppliers. What's the product for you Advanced Protection. Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Instant Hand Sanitizer (Batch: TG01) Whealthfield s Lohmann (S) Pte Ltd Acetaldehyde 13 TP 706 Hand Sanitiser (Exp: 10/3/2022) Topseller Pte Ltd Acetaldehyde and methanol 14 Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) Unilever Singapore Pte Ltd Acetaldehyde Triethanolamine can cause irritation and inflammation to eyes, skin, and hair. When using this product keep out of eyes, ears, and mouth. Supervise children under 6 years of age when using this product to avoid swallowing. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. Protects against 99.9% of germs and is proven to be effective against Covid-19 Coronavirus. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. HUMAN OTC DRUG. Product Information. Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. 75339-751-02 This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Products labeled with harmful or poisonous ingredients, such as methanol. SPL UNCLASSIFIED SECTION. FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. 75821-002-02 74721-0001-3 Godrej Protekt Hand Sanitizer. Is being recalled by the manufacturer or distributor. Topical Solution. Lifebuoy Hand Sanitizers: Instant germ protection solution recommended by doctors. 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. FDA recommended the company recall on 06/01/2022. The new additions contain a. Not all recalls will lead to press releases. 71120-112-08 The big difference between rubbing alcohol and hand sanitizer is that rubbing alcohol contains denaturants. Route of Administration. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Do not pour these products down the drain or flush them. Klar and Danver Instant Hand Sanitizer. 74721-0001-4 Rub hands together, ensuring that the sanitizer goes all over front and back of the hands. 75339-751-05 When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. 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. Target's Born Basic and Walmart's Scent Theory bring the expanded list of recalled sanitizers to more than 75. 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. Filter products The Health Sciences Authority (HSA) of Singapore has recently recalled 18 sanitizers, this includes products from Lifebuoy, Walch, Guardian and more. . This is a question our experts keep getting from time to time. Modesa Instant Hand Sanitizer Moisturizers and . Grapefruit Extract, 74721-0010-1 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 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. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 Small doses of triethanolamine are approved, but too much will be harmful. The Good Gel Antibacterial Gel Hand Sanitizer. 74721-0010-2 74530-011-04 . Sophora Extract 75339-751-03 71120-611-08 The recalls were carried out on a Class 2 level, which is a wholesale level. 71120-112-11 If soap and water are not readily available, the Centers 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). In conjunction with the U.S. Food and Drug Administration, 4E Brands has expanded its recall to include ALL lot codes of this product due to the potential presence of methanol (wood alcohol). Cannot kill bacteria and germs? 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. 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. 74721-0020-2 Safe antimicrobial activity for surgical hand disinfection within 90 seconds. Made in Korea. Comprehensive antimicrobial activity for hygienic hand disinfection within 30 seconds. 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. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. 74530-013-07 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. The Health Science Authority (HSA) has announced a wholesale-level recall of hand sanitisers. 75821-002-03. 74721-0001-2 What is simplifying rational expressions? FDA recommended the company recall on 06/01/2022. alcohol gel. 75821-002-01 74721-0020-7 Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. In case of contact, rinse eyes thoroughly with water. The recalled brands contain methanol, a chemical used to create fuel and antifreeze. Rub hands together until dry - Supervise children under 6 years of age when using this product to avoid swallowing. an essential oil, such as tea tree oil or lavender oil, or you can use lemon juice instead. Lifebuoy Hand Sanitizer - 75% Ethyl Alcohol. The world health organisation recommends to use an alcohol based hand sanitizer when out of home to prevent the spread of bacteria and virus. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. 71120-112-10 Place enough product on hands to cover all surfaces. 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. Stop supplying specified batches of the product and return the remaining stocks to the company. Individuals with compromised immune systems are at increased risk. 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. 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. 18 hand sanitisers have been recalled. The FDA has advised consumers not to use this hand sanitizer. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. Between Feb-Apr, however, the Health Sciences Authority (HSA) did a recall of 18 hand sanitiser products, including those from Guardian, Lifebuoy, FairPrice, and Cuticura. 75339-751-04 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). Gigi's Goodbye Germs Hand Sanitizer. 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. 75821-001-03 [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. Just apply to hands and rub until dry. Lifebuoy Hand Sanitizer Gel - 50mL NPN 80103793 BUY NOW 71120-112-06 Sophora Extract Mint Oil LIFEBUOY HAND SANITIZER75 PERCENT- alcoholgel Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022. 80969-020-04 Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. 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. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. Modesa Instant Hand Sanitizer Moisturizers and Vitamin E. CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol. Inactive ingredients. The dangers of drinking any hand sanitizer under any conditions. Instant Sanitizer is the ultimate convenience, one spray easily covers the entire hand. Body wash ; Sanitizer ; Bar soap ; Hand wash . 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. This is the full list of the hand sanitizers affected in this recall: Aerochem Liquid Hand Cleaner 70% Alcohol. #06-13/14 [emailprotected] Welcome to Sharing Culture! 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. 74530-015-02 Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). Take some flour in a bowl and add some hand sanitizer to it. 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. 75821-001-02 Soothing. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Stop use and ask a doctor if irritation or rash occurs. 74721-0010-8 UNILEVER ASIA PRIVATE LIMITED. 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). Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. 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. 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). Consumers who have products on thelist of hand sanitizerswith potential contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. Products. With the second wave of pandemic hitting India and no lockdown at hand, it is quite obvious that the citizens will have to go about their normal lives . 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. Cultivation Republic (Clearwater, Florida). 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.

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