Company tested product lot 2004090090; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. 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. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 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). Family size (1 L), Good Spirits Distilling Advanced Hand Sanitizer. Stay clean and germ free. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. 74046-004-04 Product Number: 849AB/BA Product Name: Moisturizing Hand Sanitizer Issuing Date: April 22, 2020 Revision Date: None Revision Number: 0 Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. 80969-020-04 Aloe Vera Based Hand And Skin Purifying Gel. 79279-610-01 ADVERTISEMENT. 79279-521-02 Products labeled with harmful or poisonous ingredients, such as methanol. FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. 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. 74721-0020-1 74721-0010-9 Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. 74530-011-06 Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. 74721-0001-6 Report any health product adverse events or complaints to Health Canada. Acetal can irritate the upper respiratory tract, eyes, and skin. 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. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. 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. 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 01/05/2023, 74046-004-01 Lukas Flippo, Photo Editor. FDA tested product; contains unacceptable levels of acetaldehyde and acetal;Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023. Suite #166 Las Vegas, NV 89139";FDArecommended the company recallon11/3/2021;product voluntarilyrecalledon11/4/2021, Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer, SBL Brands LLC dba Global Sanitizers LLC(Nevada), FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Anitmicrobial Formula, Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020, WelburnGlobal SociedadAnonima(Guatemala), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven after receiving a warning letter. 71120-612-07 Do not pour these products down the drain or flush them. Company tested product; contains benzene. 74046-001-08 Safety officials at the Food and Drug Administration are warning Americans that not all hand sanitizers are made equal,. The .gov means its official.Federal government websites often end in .gov or .mil. 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). The agency first warned consumers in June about hand . For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. 74721-0020-0 Sophora Extract 79279-520-09 74721-0002-6 What to do: Stop using the identified product lots below. Before sharing sensitive information, make sure you're on a federal government site. GSD Advanced Hand Sanitizer - 80% Alcohol Based - ( 1 Liter) $15.50 + $11.63 shipping. The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDAs temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. 74721-0002-1 Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 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. The pouch is resealable to ensure your wipes are always fresh. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. Alcohol Antiseptic 75% Topical Solution Hand Sanitizer. 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. CLARKSBURG, W.Va. (WBOY) A hand sanitizer that was sold over the internet nationwide is being recalled because the company that manufactured it says it may have been contaminated with a toxic chemical. The ITECH 361 recall is for 18,940 bottles of All Clean hand sanitizer sold in one-liter bottles with UPC Code 628055370130. List of antiseptic or antibacterial skin cleansers or hand sanitizers meeting Health Canada's requirements for safety, effectiveness and quality, for use against coronavirus (COVID-19). Transliquid. Individual Warp Wipes can use anywhere you need to clean hands or there's no water available. 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. LOS ANGELES - Global Sanitizers, a wholesale producer, manufacturer and distributor of sanitizer solutions announced Thursday that is is voluntarily recalling 50,000 units of Medically Minded. Do not pour these products down the drain or flush them. Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? FDA tested product; contains acetaldehyde and acetal contaminants. Product contains methanol based on information provided by the manufacturer. 74046-006-04 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. 74530-013-08, 74530-012-01 FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. 74530-011-08, 74530-013-01 79279-610-02 The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohols source. GSD All Purpose Liquid Sanitizer & Disinfectant MEGA REFILL SIZE 1.75L (59.2 OZ) 80% ALCOHOL GSD All Purpose Liquid Sanitizer & Disinfectant FAMILY SIZE 1L (33.2 OZ) 80% ALCOHOL GSD All Purpose Liquid Sanitizer & Disinfectant POCKET SIZE 375mL (12.6 OZ) 73% Alcohol - Gel Sanitizer & Disinfectant With Essential Oils 73% ALCOHOL 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. 74046-006-02 Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. 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). Grapefruit Extract, 74721-0001-1 79279-620-02 Call 9-1-1 if the person is unconscious or has trouble breathing. MIAMI (CBSMiami) - The Food and Drug Administration has added four brands of hand sanitizer to a list of more than 75 that have been recalled. 74530-012-03 Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. 74721-0010-2 Medically Minded Hand Sanitizer Gel V-KLEAN DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages) V-KLEAN Hand Sanitizer Gel V-KLEAN Hand Sanitizer Gel. This organic hand sanitizer, which contains 62% alcohol, is formulated with glycerin and dimethicone, which together help hydrate and moisturize the skin, according to EO . 79279-620-03 75339-751-03 74046-001-11 FDA recommended the company recall all drug products on 12/12/2022. 80969-010-06 75821-002-03. Oct 9 2021, 10:23 am. In the letter, company asked the FDA to recall the contaminated batches of hand sanitizer, conduct an investigation of the products, and provide information to the public, among other things. Health Canada has suspended the product licence for two of . 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. No rinse needed, usable anywhere without water. [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. Updated: Nov 9, 2022 / 01:55 PM EST. 74046-004-07 74530-011-05 74530-013-03 79279-420-03 FDA tested product; contains unacceptable levels of acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination. Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 74721-0020-6 Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. 74530-012-05 74530-015-02 79279-421-08 GSD All Purpose Liquid Sanitizer & Disinfectant FAMILY SIZE 1L (33.2 OZ) 80% alcohol, quick dry, with no residue. Add to cart. 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. 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. 74530-015-05 79279-421-10 Harmonic Nature S de RL de MI (Mexico) FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added to import alert to stop products from entering the U.S. on 8/20/2020; product voluntarily recalled on 8/14/2020. [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. Add to Cart Overview GSD Liquid Hand Sanitizer kills more than 99.99% of the most common germs. 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. 74721-0020-8 distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. Real Clean Distribuciones has recalled its Scent Theory Keep Clean and Keep It Clean, Born Basic, and Lux Eoi hand sanitizers, The Miami Herald found. The FDA listed the following products in its warning: All-Clean Hand Sanitizer (NDC: 74589-002-01) Esk Biochem Hand Sanitizer (NDC: 74589-007-01) CleanCare NoGerm Advanced Hand Sanitizer 75% . About this item No animal testing for beauty products 3rd-party certification required for organic claims on body care products Product Description Body Care Product details 79279-520-06 FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; FDA issued a warning letter on 01/30/2023. 7 and the U.S. Food & Drug Administration (FDA) posted the recall notice on the same date. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 11/29/2022. 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. 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. Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 Artnaturals Hand Sanitizer Infused with Jojoba Oil, Germ Free Anti-Bacterial Instant Hand Sanitizer, Apollo Instant Hand Sanitizer Anti Bacterial, Health & Wellness Essentials Hand Sanitizer Wash-Free, New Sanicol Advanced Antibacterial Hand Sanitizer, National Travel Products, Inc (New Jersey), 74530-015-01 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. 74721-0010-8 We will ensure that your family stays protected from dust. 71120-611-08 74046-004-08 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. 74721-0002-4 $8.19. If swallowed, call a poison control centre or seek medical help immediately. Certain hand sanitizers are being recalled because they do not meet Health Canada's requirements. 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. 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. 74721-0010-7 79279-521-01 74046-004-03 Mint Oil Transliquid. 74046-001-16 The affected products are packaged in 4-ounce, 8-ounce, 16-ounce, and one-gallon bottles and were sold through online sales and retail . 71120-112-06 74721-0010-4 Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. 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. 74046-004-05 74721-0001-3 74046-006-06 The US Food and Drug Administration has expanded its warning about hand sanitizers to avoid, with the list now topping 100. 71120-112-10 First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. 79279-420-05 GSD Advanced Hand Sanitizer. In a public advisory notice. 75339-751-04 74721-0001-9 Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. When the FDA continues to issue recalls for the inclusion of potentially toxic ingredients (as of this release, the list of banned sanitizers has now surpassed 100), we all need a hand sanitizer . To date, the FDA's ongoing testing found methanol contamination in hand sanitizer products ranged from 1 percent to 80 percent. Alcohol antiseptic 80% topical solution. 74046-001-12 74530-011-07 Don't drink this: Hand sanitizer recalled over packaging. Sophora Extract 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). 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. 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.