Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. 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. 74046-001-17 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 The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to thelistof hand sanitizers consumers should not use. 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. The agency tweeted on Monday about the two latest recalls. Contact your local waste management and recycling center for more information on hazardous waste disposal. The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol. 74046-001-03 If swallowed, call a poison control centre or seek medical help immediately. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. 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. Canada's health agency has added three more hand sanitizer products to its growing list of 48 recalled items which began in the spring of 2021. Products labeled with harmful or poisonous ingredients, such as methanol. The US Food and Drug Administration has expanded its warning about hand sanitizers to avoid, with the list now topping 100. 74530-011-05 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. 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. 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. Alcohol Antiseptic 75% Topical Solution Hand Sanitizer. 79279-610-04 74530-012-05 Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 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 . To help limit the spread of COVID-19, wash your hands often with soap and water for at least 20 seconds. 74530-012-06 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. 74530-011-07 (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 Never eat or drink hand sanitizers, as swallowing even small amounts can be dangerous or fatal. (Florida), Salon Technologies International Sanitizing Hand Spray 80%. 74046-001-10 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. Health Canada has recalled the following products . 74530-011-06 79279-420-04 Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. 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. 70% Alcohol Cleansing Gel Say Goodbye to Germs. 74530-013-05 74530-015-03 by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 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. 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). 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. Suite #166 Las Vegas, NV 89139" FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion;Product labeled as handsanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. We will ensure that your family stays protected from dust. 74530-011-04 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. 74046-006-04 Updated: Jul 13, 2020 / 11:49 AM PDT. ], Alcohol Antiseptic 75% Topical Solution Hand Sanitizer, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to, Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico), HF&N Lab Medi Care Alcohol Antiseptic Topical Solution, 77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, SBL Brands LLC dba Global Sanitizers LLC (Nevada), Alcohol Antiseptic 70% Solution or 80% Solution, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to, TriCleanz (labeled with Made in Mexico), TriCleanz Tritanium Labs Hand Sanitizer (labeled with Made in Mexico), Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Industrias Cklass Foaming Hand Sanitizer with Aloe, Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to, Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinmicas S de RL de CV (Mexico), Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, MVP Sanitizing Services Spray Hand Sanitizer, Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily, Leipers Fork Distillery Bulk Disinfectant per 5 gallon and Leipers Fork Distillery 16 oz bottle, Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to, Liqesa Exportacion or Liq-E-SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to, Optimus Lubricants Instant Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to, The Crme Shop Moisturizing Hand Sanitizer, Peppermint Scented, FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to, Company tested product; contains methanol; product voluntarily recalled by, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily, Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily, Neoingenium Labs SA de CV Hand sanitizer (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to, Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China), Best Brand Consumers Products, Inc. (New York), Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022;added manufacturer to, FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations, Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to, FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Noticias Mexico Hoy Grupo Multimedia (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to, Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; added manufacturer to, Product purported to be made at the same facility that produced subpotent product; added manufacturer to, Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer, Real Clean Distribuciones SA de CV (Mexico), Born Basic.
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