The company announced the recall on Mar. The FDA has published a long list of hand sanitizers that they do not recommend for use. (NEXSTAR) American Screening LLC is voluntarily recalling 153,336 units of hand sanitizer that are packaged in containers that look like water bottles and pose a risk of consumption. 74046-001-04 Do not pour these products down the drain or flush them. Never eat or drink hand sanitizers, as swallowing even small amounts can be dangerous or fatal. 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). Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. 80969-040-04, PFA Stronghold Hand Sanitizer GSD Disinfecting Sanitizing Wipes can be used for everyone. 75339-751-02 74046-001-11 75339-751-04 Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on September 1, 2020, and established a limit for methanol in alcohol of 200 parts per million (ppm). Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. 71120-612-06 (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 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. Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. 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. 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): The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. 74046-004-04 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. 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 74530-011-04 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. 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. (Michigan). 74721-0010-4 The hand sanitizers include brands sold at Sam's Club and BJ's Wholesale Club. 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. 74046-004-09 A company is recalling its hand sanitizers because they may contain impurities that could cause cancers through long-term exposure, according to a notice from the U.S. Food and Drug. 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. Unibeleza Industria E Comercio De 79279-421-10 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). 74530-013-04 74046-006-04 74530-013-08, 74530-012-01 Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). 79279-620-01 GSD Hand Sanitizer, Hand Sanitizer, 33.8 Ounce Brand: GSD Hand Sanitizer 3 ratings Currently unavailable. Is purportedly made. Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. 74721-0020-5 Individual Warp Wipes can use anywhere you need to clean hands or there's no water available. 70% Alcohol Cleansing Gel Say Goodbye to Germs. $8.19. 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. Health Canada has recalled several hand sanitizers across the country over the last two years over concerns of potential health risks from using the products. Flavor Vapors, LLC, dba: Mob Liquid Labs 79279-620-05. The site is secure. Do not pour these products down the drain or flush them. 74530-011-05 UL did not test, certify, or approve the substance described in this SDS, and 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. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. 74046-001-18 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. Add to cart. 79279-520-06 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). 74721-0002-5 An independent pharmacy and lab conducted a study of hand sanitizers sold during the pandemic and found that samples from 44 of them contained benzene, a chemical known to cause leukemia. The agency will provide additional information as it becomes available. GSD Advanced Hand Sanitizer Dosage form: gel, metered Ingredients: ALCOHOL 0.7mL in 1mL Labeler: JoCo Sales & Marketing, Inc. NDC code: 77784-000 Medically reviewed by Drugs.com. Transliquid. 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). 74721-0002-4 The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. 75293-001-04 The US Food and Drug Administration has expanded its warning about hand sanitizers to avoid, with the list now topping 100. 74530-012-07 No rinse needed, usable anywhere without water. 75339-751-03 79279-420-02 74530-011-03 First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. 71120-112-08 Add to Cart Overview GSD Liquid Hand Sanitizer kills more than 99.99% of the most common germs. 79279-610-03 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 . 74721-0020-8 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. Sophora Extract 79279-521-04 FDAs investigation of methanol in certain hand sanitizers is ongoing. 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. 75339-751-05 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Dongguan Mingyi Medical Products, Co., Ltd. You should look for lot number 1166A and expiration date 6/18/2023 on the container. 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. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. 75293-001-01, Coppercraft Distillery, LLC FDA recommended the company recall on 06/01/2022. We will ensure that your family stays protected from dust. Some of the products have already been recalled. 74530-013-05 In late June, the agency issued a warning against purchasing. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. EO Hand Sanitizer Gel. 74046-004-07 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. Grapefruit Extract, 74721-0001-1 Innovaciones Tecnologicas Concar, SA de CV Consumers can easily identify which hand sanitizer products to avoid by using the following information: Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. 71120-112-06 Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. The recalls were issued on October 8 after undeclared impurities were found in the sanitizers. 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. Call Poison Help at 800-222-1222 to connect to your local poison center. To date, the FDA's ongoing testing found methanol contamination in hand sanitizer products ranged from 1 percent to 80 percent. GSD Advanced Hand Sanitizer Drug Facts Active ingredients Ethyl alcohol 70% v/v Purpose Antimicrobial Use 71120-112-05 74046-004-08 Call 9-1-1 if the person is unconscious or has trouble breathing. 74046-006-07 Transliquid. 74046-001-09 Mint Oil The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. The pouch is resealable to ensure your wipes are always fresh. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 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. 74046-001-17 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. Hand Sanitizer Sold Nationwide Recalled Due to Health Concerns, FDA Warns Even though it's long been available to customers, the COVID-19 pandemic certainly changed the rate at which we buy. 74721-0002-6 74046-004-03 80969-010-07 Free shipping. 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. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. 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 is not aware of any adverse events related to Durisans hand sanitizer products. 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% . 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 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Certain hand sanitizers are being recalled because they do not meet Health Canada's requirements. Anti-Bac Hand Sanitizer 65% Alcohol, Scent Theory Keep It Clean Pure Clean Anti-bacterial Hand Sanitizer, Cavalry (labeled with Product of Mexico), Natural Gold Gel Alcohol Antiseptic 75% Topical Solution, Command Gel AntiBac Instant hand sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily, UltraCruz Hand Sanitizing Gel Antimicrobial, Company tested product; isopropyl alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020, Sanit Technologies LLC, doing business as Durisan (Florida), Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-Free, Company tested product; contains microbial contamination; product, Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free, New Wave Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%), Company tested product; manufacturing process lacks adequate controls to prevent microbial contamination. Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. 79279-521-01 $80.00. 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). 79279-420-05 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. 79279-420-03 Benzene may cause certain types of cancer in humans. 79279-620-04 74721-0010-2 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. [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. Topical Solution. This recall is being conducted with the knowledge of the FDA. 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. Need help now? 80969-020-03 79279-521-05 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. ADVERTISEMENT. 80969-008-01, 80969-010-01 79279-610-02 What to do: Stop using the identified product lots below. This comes after a series of recalls related to. 74721-0010-8 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. 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.
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