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. 74046-001-07 Company tested product; contains benzene. 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. 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. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. Barry Butler, the owner of Tarpon Springs Distillery in Tarpon Springs, Fla., had teamed up with a nearby rum distillery to give away about 15,000 gallons of sanitizer and had made $40,000 by . We don't know when or if this item will be back in stock. A hand sanitizer that was sold over the internet nationwide is being recalled because it may have been contaminated with toxic methanol. 75821-001-03 Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. 74046-006-08 Scentsational Soaps & Candles, Inc. issued a voluntary recall on the spray . 74721-0020-7 The pouch is resealable to ensure your wipes are always fresh. 8 Pack 80% Alcohol Naturewell Advanced Liquid Hand Sanitizer Made In USA. 75821-001-02 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. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. Contact your local waste management and recycling center for more information on hazardous waste disposal. 74530-011-03 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. $80.00. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Dongguan Mingyi Medical Products, Co., Ltd. The hand sanitizers include brands sold at Sam's Club and BJ's Wholesale Club. Maridav/Shutterstock. 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. 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. 08/11/2020. The agency has recalled hand sanitizers from the companies All-Clean, Eskbiochem, CleanCare, Saniderm, Lavar 70 and Good Gel, which were all manufactured by Mexico-based Eskbiochem SA de CV.. 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 ITECH 361 recall is for 18,940 bottles of All Clean hand sanitizer sold in one-liter bottles with UPC Code 628055370130. 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 been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. 75821-002-03. EO Hand Sanitizer Gel. 71120-612-07 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 74046-001-17 If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. FDA recommended the company recall on 06/01/2022. UL did not test, certify, or approve the substance described in this SDS, and 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. Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. Safety officials at the Food and Drug Administration are warning Americans that not all hand sanitizers are made equal,. For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Company tested product; 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 Associated lot numbers: Company tested product lot 200423322; 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. The company announced the recall on Mar. 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. The four products added to the recall list. 74530-012-07 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. 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. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer 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. Products labeled with harmful or poisonous ingredients, such as methanol. (China). FDA tested product; contains acetaldehyde and acetal contaminants. 75339-751-02 (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 79279-521-04 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. 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. Individual Warp Wipes can use anywhere you need to clean hands or there's no water available. Picture Information. 74530-013-03 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. 74721-0002-1 74046-004-09 $19.95. 74046-001-03 74046-006-04 Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Acetal can irritate the upper respiratory tract, eyes, and skin. 74046-006-10. 74530-011-06 The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. 74046-001-09 Alcohol antiseptic 80% topical solution. Hand sanitizer is a great way to keep your hands clean while in public. 75339-751-04 GSD Advanced Hand Sanitizer - 80% Alcohol Based - ( 1 Liter) $15.50 + $11.63 shipping. That chemical, according to the recall posted on the U.S. Food and Drug Administration's website, is . 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 . 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. 71120-611-07 Need help now? Do not pour these products down the drain or flush them. Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. 74721-0020-5 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). 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. 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 FDA announced a recall for a specific hand sanitizer. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. On March 26, students, faculty and staff were notified in an email from Yale's Environmental Health & Safety Department, or EHS, that benzene, a substance that can cause cancer, was detected in two hand sanitizer brands distributed by Yale, CleanHands and ArtNaturals, and were asked to dispose of the hand . 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. 74721-0002-6 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. 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. Call 9-1-1 if the person is unconscious or has trouble breathing. 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. Do not pour these products down the drain or flush them. Some of the products have already been recalled. Hand sanitizer recall: FDA expands list of 'toxic' sanitizers to avoid over methanol risk by: Alexa Mae Asperin. 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 . 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. 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). 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. Has been tested and is found to have microbial contamination. 74721-0002-3 Unibeleza Industria E Comercio De Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. Topical Solution. 74046-001-06 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. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? GSD All Purpose Liquid Sanitizer & Disinfectant FAMILY SIZE 1L (33.2 OZ) 80% alcohol, quick dry, with no residue. 74046-001-16 Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 We will ensure that your family stays protected from dust. 74046-001-10 Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. 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]. Do not pour these products down the drain or flush them. It was distributed nationwide to wholesale distributors and retailers. Before sharing sensitive information, make sure you're on a federal government site. 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). FDA recommended the company recall all drug products on 12/12/2022. [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.