Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including, but not limited to, purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol, and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. 33.8 oz. 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. 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). Herbacil Antiseptic Hand Sanitizer 70% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily, Soho Fresh Hand Sanitizer Gel Antibacterial, FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to, SOHO Fresh Hand Sanitizer Gel Antibacterial, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by, CALA Advanced Hand Sanitizer with Aloe Vera Extract, FDA-tested product; contains benzene; FDA recommended the company recall Lot 2004718 (Expiration 04/2023) on 12/27/2021; FDA expanded recall on 2/25/2022 to include all hand sanitizer drug products manufactured at the facility; added manufacturer to, Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced, FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, DEPQ Internacional S de RL de CV (Mexico), FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, dgreen Advanced Hand Sanitizer Antibacterial Gel, Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to, FDA tested product; contains methanol; addedmanufacturerto, Product purported to be made at the same facility that produced methanol contaminated product; addedmanufacturerto, Distribuidora Lagunera del Norte SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Distribuidora Lagunera del Norte SA de CV, FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, Cleaner by Crystalware Hand Sanitizer Alcohol Gel, FDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to, The Good Gel Antibacterial Gel Hand Sanitizer, CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, Estrategia Hospitalaria SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to, Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to, Genesis Partnership Company SA (Guatemala), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to. Kleanz Antibacterial Hand Sanitizer Advanced, Be Safe Hand Sanitizer (labeled with Model: BF-HGXXXX-09 where XXXX changes based on packaging size), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven afterreceiving a warning letter. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. 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. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. 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 Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. Has been tested and is found to have microbial contamination. Some of the products have already been recalled. $80.00. Before sharing sensitive information, make sure you're on a federal government site. 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 09/27/2022; product voluntarily recalled on 9/27/2022. The US Food and Drug Administration has expanded its warning about hand sanitizers to avoid, with the list now topping 100. Do not pour these products down the drain or flush them. 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. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 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. 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. Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. EO Hand Sanitizer Gel. (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 80969-040-04, PFA Stronghold Hand Sanitizer 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. It was only four months ago that hand sanitizers became one of the hottest products to fly off the shelves around the world to help stave off the coronavirus. 74721-0001-8 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. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 74530-012-06 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. 79279-520-09 74721-0002-8 Flavor Vapors, LLC, dba: Mob Liquid Labs 74046-001-06 79279-520-07 74721-0020-2 In a public advisory notice. 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. Recalled hand sanitizers The following products have been recalled as of July 18: ITECH 361's All Clean Hand Sanitizer, Moisturizer and Disinfectant : UPC code 628055370130. 74530-013-07 74721-0020-7 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. Family size (1 L), Good Spirits Distilling Advanced Hand Sanitizer. Is purportedly made. 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 Updated: Nov 9, 2022 / 01:55 PM EST. Health Canada has issued a recall for 19 hand sanitizers because they may pose health risks. No rinse needed, usable anywhere without water. 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. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 74530-011-02 Call 9-1-1 if the person is unconscious or has trouble breathing. 74721-0001-3 Last updated on May 17, 2022. The company, Spartan Chemical, issued a recall for its "Lite 'n Foamy Lemon Blossom Hand Sanitizer" and "foamyiQ Lemon Blossom Hand Sanitizer" on July 1. 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. The Food and Drug Administration has expanded the list of hand sanitizers some sold at Walmart, Costco and other national chains being recalled to at least 75 recently, saying toxic. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021. For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 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 CNN Two lots of Disney-branded hand sanitizer featuring Mickey Mouse and baby Yoda from The Mandalorian have been voluntarily recalled by Best Brands Consumer Products, according to a. The Colorado-based company issued a voluntary recall of 20 lots of Adam's Polishes Hand Sanitizer to the consumer level in "an abundance of caution" after the FDA found one lot had contained. Hand Sanitizer Industrial and Hospital Grade, FDA tested product; ethyl alcohol level was subpotent; added to, Guangzhou Youxing Cosmetics Co. Ltd.(China), V&W Advance Hand Sanitizer Refreshing Gel, Guangzhou Youxing Cosmetics Co. Ltd. (China), V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc. 79279-420-02 74046-006-04 Category: Hand Sanitizer. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. 79279-620-03 Tennessee Technical Coatings Corp. is voluntarily recalling all lots of its isopropyl alcohol antiseptic 75% hand sanitizer. 74046-001-12 80969-008-01, 80969-010-01 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. 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 . 74721-0001-9 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. [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. 74046-001-17 80969-020-04 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 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. Health Canada has recalled the following products . The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. FDA recommended the company recall on 06/01/2022. 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. 74046-001-08 GSD Advanced Hand Sanitizer - 80% Alcohol Based - ( 1 Liter) $15.50 + $11.63 shipping. We don't know when or if this item will be back in stock. Artnaturals has been added to the list. 74721-0001-2 74046-001-02 74721-0010-4 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. One product is also improperly labelled. Safety officials at the Food and Drug Administration are warning Americans that not all hand sanitizers are made equal,. We will ensure that your family stays protected from dust. Mint Oil 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. Add to cart. 79279-610-05 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). Add to Cart Overview GSD Liquid Hand Sanitizer kills more than 99.99% of the most common germs. On June 19, 2020, the U.S. Food and Drug Administration (FDA) advised consumers not to use any hand sanitizer manufactured by "Eskbiochem SA de CV" in Mexico, due to the potential presence of methanol, a "toxic alcohol", as an active ingredient, which can cause blindness and/or death when absorbed through the skin or when swallowed. 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. This recall is being conducted with the knowledge of the FDA. 74721-0020-0 Picture Information. Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 74530-013-03 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. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. 71120-112-05 74530-011-03 74530-015-06, 74530-011-01 The ITECH 361 recall is for 18,940 bottles of All Clean hand sanitizer sold in one-liter bottles with UPC Code 628055370130. 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. 75339-751-05 74721-0002-3 The affected products are packaged in 4-ounce, 8-ounce, 16-ounce, and one-gallon bottles and were sold through online sales and retail . 74046-001-11 Company tested product; contains benzene. 80969-010-07 74530-013-06 FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. 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. 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 all drug products on 12/12/2022. The pouch is resealable to ensure your wipes are always fresh. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Consult your health care professional if you have used any of these products and have health concerns. 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. 74046-001-04 79279-420-05 74046-006-03 While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal. 71120-112-11 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. 74721-0002-6 80969-007-01 It was distributed nationwide to wholesale distributors and retailers. 74046-001-20. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA updates on hand sanitizers consumers should not use, 10/12/2021: FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers, 10/4/2021: UPDATE - FDA advises consumers not to use certain artnaturals hand sanitizers, local waste management and recycling center, Centers for Disease Control and Prevention, 3/25/2021: UPDATE - FDA warns consumers not to use Durisan Antimicrobial Solutions recalled Hand Sanitizer Alcohol-Free due to microbial contamination, 1/26/2021: PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers, 1/19/2021: UPDATE - FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency, 8/27/2020 PRESS RELEASE - COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers, 8/24/2020: UPDATE FDA provides testing method to assess the quality of hand sanitizer products for impurities, 8/12/2020: UPDATE - FDA expands hand sanitizer warnings to include 1-propanol contamination, 8/7/2020: UPDATE - FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers, 7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products, 7/27/2020 PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products, 7/2/2020: UPDATE- FDA warns consumers of risk of methanol contamination in certain hand sanitizers, 7/2/2020 PRESS RELEASE - FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, 6/19/2020 ALERT - FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem.
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