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. 74530-015-03 The company recalled one lot of hand sanitizer: Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. 71120-112-11 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. 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. 74721-0010-5 $8.19. The newest recalled hand sanitizers are: 74721-0002-7 74530-013-04 Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. 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. Now, about five dozen different. 74046-006-08 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 However, consistent with FDAs temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. 74046-006-06 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. 80969-010-06 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 acetaldehyde and acetal contaminants. 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. 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). Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 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. 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. 79279-420-05 Topical Solution. 74721-0020-6 The affected products are packaged in 4-ounce, 8-ounce, 16-ounce, and one-gallon bottles and were sold through online sales and retail . Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. Consult your health care professional if you have used any of these products and have health concerns. 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 . 74530-012-03 UL did not test, certify, or approve the substance described in this SDS, and (China). April 30, 2021 -- Nearly a dozen scented hand sanitizer sprays sold at Ulta, TJ Maxx, and Marshalls stores nationwide are being recalled because they may be contaminated with methanol, a. 75293-001-01, Coppercraft Distillery, LLC Grapefruit Extract, 74721-0001-1 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. It also reported that Target sold Born Basic Anti-Bac Hand Sanitizer, while Walmart sold Scent Theory at stores in 17 states. 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. Pleasant scent and safe for sensitive skin. 74046-006-07 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 74721-0001-0 74530-012-07 74046-004-03 GSD Advanced Hand Sanitizer - 80% Alcohol Based - ( 1 Liter) $15.50 + $11.63 shipping. The recalls were issued on October 8 after undeclared impurities were found in the sanitizers. An official website of the United States government, : 74046-001-17 containers resembling food pouches labeled with childrens characters, including Barbie, Hot Wheels, Paw Patrol, Minions, JoJo Siwa Dreamer and Trolls World Tour, Hand sanitizer products packaged in containers resembling food pouches commonly used for childrens applesauce and other pureed foods that present increased risk of accidental ingestion by children; FDA recommended the distributor recall on 9/21/2020; this advisory does not extend to Smart Care products in other types of packaging; product voluntarily, Lite n Foamy Lemon Blossom Hand Sanitizer, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020 and on 3/29/2021; FDA issued a, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020; FDA issued a, Private D Capital Group Corp., Human Choice LLC and RediBag USA Astrum LLC, Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to, SIREtizer Alcohol Antiseptic 80% Topical Solution Hand Sanitizer. One product is also improperly labelled. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Keep all hand sanitizers out of the reach of children. 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. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. The site is secure. 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). The product, which contains 70% ethyl alcohol gel, comes in 8-ounce bottles and is intended to be . 74530-012-06 74721-0010-7 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 toHSDoNotUseListInquiries@fda.hhs.gov. 75821-002-01 Don't drink this: Hand sanitizer recalled over packaging. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. 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. 70% Alcohol Cleansing Gel Say Goodbye to Germs. 71120-112-08 (Michigan). [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. 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. 79279-421-07 by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 74046-001-09 71120-117-02, 75821-001-01 Valisure . 75821-002-02 Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. GSD Hand Sanitizer, Hand Sanitizer, 33.8 Ounce Brand: GSD Hand Sanitizer 3 ratings Currently unavailable. 75821-001-03 Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 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. 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. 74721-0020-2 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. 74046-001-18 74046-001-05 This comes after a series of recalls related to. 79279-521-04 Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021. Products labeled with harmful or poisonous ingredients, such as methanol. Is purportedly made. World Health Organization formula. 74721-0020-7 Company tested product; contains benzene. 79279-610-01 Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. Sophora Extract 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. 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. 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 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. 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). Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. 79279-520-09 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.. Stay clean and germ free. 74721-0002-8 74530-013-07 Health Canada has suspended the product licence for two of . 74721-0002-4 71120-612-06 7 and the U.S. Food&Drug . 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. 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. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. 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. 74046-004-09 The new additions cont Artnaturals Hand Sanitizer Infused with Jojoba Oil, Germ Free Anti-Bacterial Instant Hand Sanitizer, Apollo Instant Hand Sanitizer Anti Bacterial, Health & Wellness Essentials Hand Sanitizer Wash-Free, New Sanicol Advanced Antibacterial Hand Sanitizer, National Travel Products, Inc (New Jersey), 74530-015-01 Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). Recalled hand sanitizers The following products have been recalled as of Aug. 1: ITECH 361's All Clean Hand Sanitizer, Moisturizer and Disinfectant : UPC code 628055370130. Health Canada has issued a recall for 19 hand sanitizers because they may pose health risks. 74046-004-05 79279-610-02 The agency first warned consumers in June about hand . The agency will provide additional information as it becomes available. 74046-001-03 74046-001-16 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). 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). For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDAs temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. 79279-610-03 Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. 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. 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. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Benzene may cause certain types of cancer in humans. 74721-0001-7 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. Mint Oil 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. FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. 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. Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 75821-001-02 Some of the products have already been recalled. ADVERTISEMENT. 74721-0010-8 74721-0020-8 Product Number: 849AB/BA Product Name: Moisturizing Hand Sanitizer Issuing Date: April 22, 2020 Revision Date: None Revision Number: 0 Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. Family size (1 L), Good Spirits Distilling Advanced Hand Sanitizer. 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. Tennessee Technical Coatings Corp. is voluntarily recalling all lots of its isopropyl alcohol antiseptic 75% hand sanitizer. FDA recommended the company recall on 06/01/2022. Flavor Vapors, LLC, dba: Mob Liquid Labs Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 74046-001-07 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. Do not pour these products down the drain or flush them. 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. 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 That chemical, according to the recall posted on the U.S. Food and Drug Administration's website, is . 74721-0001-9 74046-001-06 74721-0002-3 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. 74046-001-08 The FDA has published a long list of hand sanitizers that they do not recommend for use. Grapefruit Extract, 74721-0010-1 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. 79279-421-08 Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. What to do: Stop using the identified product lots below. 74721-0020-0 75339-751-02 $19.95. 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. It was distributed nationwide to wholesale distributors and retailers. 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. 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. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Instant action with safe ingredients - no Triclosan, Sulfates, Parabens or Synthetics. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. 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. Report any health product adverse events or complaints to Health Canada. 71120-612-07 74530-015-02 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. 79279-620-03 Guangzhou Minghui Cosmetics Co. Ltd. (China), 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; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021, Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. 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 5/16/2022; FDA issued a warning letter on 07/20/2022. 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.
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