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. 71120-112-11 Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. Oct 9 2021, 10:23 am. A hand sanitizer made by nanoMaterials Discovery Corp. has been recalled because the U.S. Food and Drug Administration said it "may exceed FDA limits for methanol." Snowy Range Blue alcohol . $ 7.99. 74721-0020-1 FDA tested product; contains acetaldehyde and acetal contaminants. 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. Keep all hand sanitizers out of the reach of children. 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. 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. The FDA included several types of. 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 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): [8/7/2020] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDAs temporary policies to help ensure that harmful levels of methanol are not present in these 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 on 11/29/2022. Do not pour these products down the drain or flush them. 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. GSD Advanced Hand Sanitizer - 80% Alcohol Based - ( 1 Liter) $15.50 + $11.63 shipping. 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). We will ensure that your family stays protected from dust. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The agency will provide additional information as it becomes available. 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). 74721-0010-9 75821-002-01 79279-421-08 74721-0020-5 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. 79279-620-03 75293-001-01, Coppercraft Distillery, LLC 80969-020-04 Call 9-1-1 if the person is unconscious or has trouble breathing. 7 and the U.S. Food & Drug Administration (FDA) posted the recall notice on the same date. Tennessee Technical Coatings Corp. is voluntarily recalling all lots of its isopropyl alcohol antiseptic 75% hand sanitizer. Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. 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. 79279-620-05. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. 74530-015-02 Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. You should look for lot number 1166A and expiration date 6/18/2023 on the container. 74530-011-02 FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. 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. Stay clean and germ free. 71120-112-05 74530-011-05 74721-0010-7 74530-012-07 The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. The company announced the recall on Mar. 74046-001-08 75821-001-04 $19.95. 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. 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. 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). 74530-011-07 74721-0002-6 79279-521-05 It also reported that Target sold Born Basic Anti-Bac Hand Sanitizer, while Walmart sold Scent Theory at stores in 17 states. 74530-012-05 Never eat or drink hand sanitizers, as swallowing even small amounts can be dangerous or fatal. Picture Information. 71120-612-07 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. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Consumers who have products on thelist of hand sanitizerswith potential contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 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. 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. 79279-620-01 74530-015-05 71120-611-07 Grapefruit Extract, 74721-0010-1 74530-015-04 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. Don't drink this: Hand sanitizer recalled over packaging. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. 74046-006-09 First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. 79279-520-09 79279-521-02 Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 74046-001-11 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 1/24/2023. 74721-0002-5 79279-620-02 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. 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 Cultivation Republic (Clearwater, Florida). CNN . 79279-610-03 It was distributed nationwide to wholesale distributors and retailers. 75339-751-02 79279-421-06 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. 74046-001-02 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. 74046-006-04 8 Pack 80% Alcohol Naturewell Advanced Liquid Hand Sanitizer Made In USA. FDAs investigation of methanol in certain hand sanitizers is ongoing. 75821-002-02 71120-611-08 33.8 oz. Need help now? Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 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. Germ-X Gel Hand Sanitizer, Bottle of Gel Hand Sanitizer with Cap, Original Scen. FDA issued, Alcohol Isopropilico Hand Sanitizer Limar, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021;product, Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to, BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to, MODESA Instant Hand Sanitizer Moisturizers and Vitamin E, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily, BLUMEN Advanced Instant Hand Sanitizer Lavender, BLUMEN Clear LEAR Advanced Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer Aloe, BLUMEN Clear Advanced Instant Hand Sanitizer Lavender, BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol, Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol, Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol, Blumen Antibacterial Fresh Citrus Hand Sanitizer, Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product, Assured Instant Hand Sanitizer (Vitamin E and Aloe), Assured Instant Hand Sanitizer (Aloe and Moisturizers), Assured Instant Hand Sanitizer Vitamin E and Aloe, Assured Instant Hand Sanitizer Aloe and Moisturizers, BLUMEN Instant Hand Sanitizer Fragrance Free, FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to, bio aaa Advance Hand Sanitizer 480 mL bottles, Product purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily, NuuxSan Instant Antibacterial Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily, Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers, Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E, Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to, Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to, DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages), SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada), Protz Real Protection Antibacterial Hand Sanitizer, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, 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, AltaioHand Sanitizing Wipes (80% Ethanol), 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;addedmanufacturerto, AltaioHand Sanitizing Wipes (70% Ethanol), Naturia Professional Green Hand Sanitizer, Essentials by Urban Secrets Hand Sanitizer, Essentials by Urban Secrets Advanced Hand Sanitizer, Botanicals Internacional SA de CV (Mexico), Alcohol Antiseptic 80% topical solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to, Total Pure Alcohol Based Hand Sanitizer Gel, Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi). 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. 74721-0002-8 For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. That chemical, according to the recall posted on the U.S. Food and Drug Administration's website, is . Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.
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