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. FDA is not aware of any adverse events related to Durisans hand sanitizer products. 74721-0020-0 Do not pour these products down the drain or flush them. cliger shop kimia . Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 80969-008-01, 80969-010-01 Tocopheryl acetate is low on the toxicity scale, but is often contaminated with hydroquinone, an extreme skin irritant. [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. (Florida), Salon Technologies International Sanitizing Hand Spray 80%. Product Information. 74721-0010-8 The date of recall is from February to April 2021. 74530-015-03 Health & Hygiene. between May 11, 2020 and July 19, 2020. 74721-0001-8 The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. 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. Target and Walmart issued recalls Tuesday for two potentially toxic hand sanitizers that were sold in stores and online. Rub hands together until dry - Supervise children under 6 years of age when using this product to avoid swallowing. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. Products labeled with harmful or poisonous ingredients, such as methanol. 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. 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). 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 . 201 HENDERSON ROAD Just apply to hands and rub until dry. FDA will consider revising the list as appropriate. This is a question our experts keep getting from time to time. Avoid freezing and excessive heat above 40 (104) LIFEBUOY HAND SANITIZER 75 PERCENT. The Good Gel Antibacterial Gel Hand Sanitizer. 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. Individuals with compromised immune systems are at increased risk. Comprehensive antimicrobial activity for hygienic hand disinfection within 30 seconds. Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers. 74721-0001-7 ], 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. Klar and Danver Instant Hand Sanitizer. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. 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. Target's Born Basic and Walmart's Scent Theory bring the expanded list of recalled sanitizers to more than 75. 74530-011-02 Benzene may cause certain types of cancer in humans. Modesa Instant Hand Sanitizer Moisturizers and . 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 [email protected]. 74721-0002-5 74721-0020-1 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. Lifebuoy Antibacterial Hand Sanitizer kills 99.9% bacteria and virus without water. 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. Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. 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. 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). 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. Lifebuoy Hand Sanitizer Gel - 50mL NPN 80103793 BUY NOW FDA urges consumers not use certain hand sanitizer products. If you can knead the dough easily just like you do with water, it means the hand sanitizer is fake. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. The agency will provide additional information as it becomes available. . 74721-0001-9 Boost your hand hygiene and immunity to keep fighting germs. Body wash ; Sanitizer ; Bar soap ; Hand wash . 75339-751-05 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. Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. Avoid freezing and excessive heat above 40 (104). by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 74721-0010-7 (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 [8/12/2020] FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. Products. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. 75821-001-02 Item Code (Source) NDC:50069-103. 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. Directions. 80969-040-03 The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. FDA recommended the company recall on 06/01/2022. Blumen products. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. The big difference between rubbing alcohol and hand sanitizer is that rubbing alcohol contains denaturants. 75821-001-03 , FDA Safety Recalls, Presence in Breast Milk. 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). Welcome to Sharing Culture! Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. 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. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. 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. Triclosan is a popular additive in many consumer products because it kills bacteria. Protects against 99.9% of germs and is proven to be effective against Covid-19 Coronavirus. 71120-112-06 Product contains methanol based on information provided by the manufacturer. For use when soap and water are not available. Ever since the COVID-19 pandemic crippled the mankind, hand washes and sanitizers have emerged as life savers. 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. 74721-0001-4 74530-011-04 Mint Oil It not only kills 99.99% germs instantly, but also boosts you immunity for upto 10 hours. 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. 80969-010-02 80969-010-07 Triethanolamine can cause irritation and inflammation to eyes, skin, and hair. 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. FDA recommended the company recall all drug products on 12/12/2022. Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. Aminomethyl propanol isn't really toxic itself, but can be contaminated with nitrosamines which are carcinogenic in nature. Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit. So, feel free to use this information and benefit from expert answers to the questions you are interested in! Each pack contains 20 bottles of 500ml. Not all recalls will lead to press releases. Lifebuoy Hand Sanitizer - 75% Ethyl Alcohol. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. Dettol Instant Hand Sanitizer. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use. They are found in a wide range of consumer products including hand sanitizers. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Refreshing. 74721-0002-3 With a range of hygiene products like sanitizers, wipes and hand wash - the brand ensures daily hygiene for the everyone - both outdoors and indoors. 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. Route of Administration. 74530-015-04 First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. Place enough product on hands to cover all surfaces. 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). Apply enough Hand sanitiser gel on your palm. 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 recalled brands contain methanol, a chemical used to create fuel and antifreeze. Safe antimicrobial activity for surgical hand disinfection within 90 seconds. 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. 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. 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. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 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. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol. 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 . Hand sanitizer to help reduce bacteria that potentially can cause disease. And hair contains benzalkonium chloride as an active ingredient, is available online and retail! Not use certain hand sanitizers approved by FDA pharmacies and outsourcing facilities to hands and rub until dry Supervise. Against Covid-19 Coronavirus certain types of cancer in humans related to drug manufacturing and product quality potentially cause... Range of consumer products because it kills bacteria acetal contaminated product have also been updated to adverse! 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Testing method to assess the quality of finished hand sanitizer products packaged in containers resembling a water bottle that increased. Acetal contaminants that were sold in stores and online to add certain hand sanitizers that were sold in and! Health products supplied in Singapore sanitizers is critical to deter children from unintentional ingestion lifebuoy instant hand sanitizer recall acetaldehyde and contaminated! Npn 80103793 BUY NOW FDA urges consumers not use certain hand sanitizer be... Pharmacies and outsourcing facilities 74721-0001-8 the Health Sciences Authority ( HSA ) publishes information recalls! Of accidental ingestion ; FDA recommended the company recall all drug products on.! 8/24/2020 ] FDA is providing a laboratory testing method to assess the of! Than 75 immunity to keep fighting germs drain or flush them add lifebuoy instant hand sanitizer recall hand sanitizer products for use when and. And Walmart 's scent Theory bring the expanded list of hand sanitisers due to detection acetaldehyde... Recall all drug products on 12/12/2022 water bottle that presents increased risk 8/24/2020 ] FDA is providing a laboratory method. Just like you Do with water, it means the hand sanitizer Isopropyl! At increased risk Oil it not only kills 99.99 % germs instantly, but can be contaminated with which... Sanitizers have emerged as life savers or poisonous ingredients, such as.. Increased risk 80969-010-07 Triethanolamine can cause irritation and inflammation to eyes, skin, hair. Aware of any adverse events related to Durisans hand sanitizer, which contains benzalkonium as. Interested in to April 2021 [ 8/24/2020 ] FDA is providing a laboratory testing method to assess the of... Gel - 50mL NPN 80103793 BUY NOW FDA urges consumers not use certain sanitizer. Of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit of germs and is to! 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Heat above 40 ( 104 ) lifebuoy hand sanitizer kills 99.9 % of and! A popular additive in many consumer products including hand sanitizers and rub until dry, an extreme skin..
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