74530-011-02 74721-0010-7 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. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 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. 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. 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. 79279-610-01 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. 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. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. 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 . Specifications Value of Product Features Most Helpful Favorable Review Good stuff ! 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. Safety officials at the Food and Drug Administration are warning Americans that not all hand sanitizers are made equal,. Contact your local waste management and recycling center for more information on hazardous waste disposal. 74721-0020-5 79279-610-02 The FDA announced a recall for a specific hand sanitizer. FDAs investigation of methanol in certain hand sanitizers is ongoing. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. 74721-0020-6 Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. Germ-X Gel Hand Sanitizer, Bottle of Gel Hand Sanitizer with Cap, Original Scen. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 FDA issued a, Yara Elena de La Garza Perez Nieto (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added manufacturer to, Product labeled to be edible alcohol; added manufacturer to. To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. Need help now? Oct 9 2021, 10:23 am. 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. Add to cart. 74046-001-14 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel 74721-0002-2 79279-520-07 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 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. Alcohol Antiseptic 75% Topical Solution Hand Sanitizer. Aloe Vera Based Hand And Skin Purifying Gel. 74721-0001-7 The FDA has published a long list of hand sanitizers that they do not recommend for use. 79279-521-04 Grapefruit Extract, 74721-0010-1 79279-620-05. 74046-006-08 A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. 74530-015-02 The FDA included several types of. 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. 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). The dangers of drinking any hand sanitizer under any conditions. 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. 74530-012-04 A hand sanitizer that was sold over the internet nationwide is being recalled because it may have been contaminated with toxic methanol. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. Products labeled with harmful or poisonous ingredients, such as methanol. There's a nationwide spray hand sanitizer recall on 11 products that were sold at Ulta, TJ Maxx, and Marshalls stores. [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. 79279-521-03 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. Benzene may cause certain types of cancer in humans. The hand sanitizers include brands sold at Sam's Club and BJ's Wholesale Club. 7 and the U.S. Food&Drug . Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; after FDA recall recommendation, the firm announced a voluntary recall on 10/18/2022; FDA issued a warning letter on 12/20/2022. 80969-010-07 Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. Topical Solution. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. Certain hand sanitizers are being recalled because they do not meet Health Canada's requirements. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. Product contains methanol based on information provided by the manufacturer. The pouch is resealable to ensure your wipes are always fresh. 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. 79279-620-01 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. 74046-001-19 74046-001-11 79279-421-08 Do not pour these products down the drain or flush them. 74721-0002-6 For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. 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. Five more hand sanitizers were added to Health Canada's evolving recall list on Tuesday, which now includes more than 100 products that may pose health risks. product voluntarilyrecalledon 11/30/2021, Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. 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 09/09/2022. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. Dongguan Mingyi Medical Products, Co., Ltd. No rinse needed, usable anywhere without water. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. 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). Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021. Category: Hand Sanitizer. 79279-620-03 [7/31/2020] FDA continues to find issues with certain hand sanitizer products. 80969-007-01 Consumers who have products on thelist of hand sanitizerswith potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 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. An official website of the United States government, : The agency also included an additional denaturant formula in the temporary guidances. 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. 74530-012-06 Health Canada has recalled the following products . The product, which contains 70% ethyl alcohol gel, comes in 8-ounce bottles and is intended to be . Hand sanitizer recall: FDA expands list of 'toxic' sanitizers to avoid over methanol risk by: Alexa Mae Asperin. Updated: Jul 13, 2020 / 11:49 AM PDT. 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. 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. 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. 80969-020-03 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. To help limit the spread of COVID-19, wash your hands often with soap and water for at least 20 seconds. Maridav/Shutterstock. Consult your health care professional if you have used any of these products and have health concerns. 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). 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. 79279-521-01 This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. 80969-010-02 74046-006-10. Unibeleza Industria E Comercio De 74721-0001-3 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. [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. In most . Scentsational Soaps & Candles, Inc. issued a voluntary recall on the spray . 74530-013-08, 74530-012-01 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. 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. 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. 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. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Company tested product; contains benzene. 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% . 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. 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. 74046-004-04 According to the FDA, you should use an alcohol-based hand. Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. ADVERTISEMENT. 74046-006-03 Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L), Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml), Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution. Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 74530-013-06 Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent. The agency will provide additional information as it becomes available. That chemical, according to the recall posted on the U.S. Food and Drug Administration's website, is . 75821-001-04 Individual Warp Wipes can use anywhere you need to clean hands or there's no water available. 79279-421-06 74721-0020-1 Mint Oil $80.00. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 8 Pack 80% Alcohol Naturewell Advanced Liquid Hand Sanitizer Made In USA. 75293-001-01, Coppercraft Distillery, LLC 74721-0020-7 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. 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. 74721-0020-9, 71120-112-01 74721-0002-1 74046-006-09 The agencys investigation of contaminated hand sanitizers is ongoing. 74046-001-20. Do not pour these products down the drain or flush them. 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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