74721-0020-2 The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. 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. View more View less. FDA urges consumers not use certain hand sanitizer products. FDA tested product; contains acetaldehyde and acetal contaminants. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Antibacterial, antimicrobial hand sanitizer to help fight germs and bacteria. Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 70% Alcohol Cleansing Gel Say Goodbye to Germs. Benzene may cause certain types of cancer in humans. Purifying. [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. Inactive ingredients. 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. With the second wave of pandemic hitting India and no lockdown at hand, it is quite obvious that the citizens will have to go about their normal lives . Sophora Extract The agency also included an additional denaturant formula in the temporary guidances. Sterillium is the classic among the alcohol-based disinfectants for hygienic and surgical hand disinfection. So, feel free to use this information and benefit from expert answers to the questions you are interested in! This makes rubbing alcohol unpalatable for human consumption. Sol-m Instant Hand Sanitizer : Alcohol: Gel: Topical: Sol-millennium Medical Inc: Human Otc Drug: 73720-0236: Sol-m Instant Hand Sanitizer : Alcohol: Gel: Topical: Sol-millennium Medical Inc: Human Otc Drug: 73720-0500: Sol-m Instant Hand Sanitizer : Alcohol: Gel: Topical: Sol-millennium Medical Inc: Human Otc Drug: 73720-1000: Sol-m Instant . 74530-013-07 Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. Excellent skin tolerability. This chemical is found in up to 40% of products. HAND SANITIZER SPRAY 100 ML / HANDSANITIZER SPRAY 100 ML. Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. Drinking even a small amount of hand sanitizer can cause alcohol poisoning in children. 75821-002-03. Call 9-1-1 if the person is unconscious or has trouble breathing. 80969-010-02 Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Show More . 74530-012-05 Instant Hand Sanitizer (Batch: TG01) Whealthfield s Lohmann (S) Pte Ltd Acetaldehyde 13 TP 706 Hand Sanitiser (Exp: 10/3/2022) Topseller Pte Ltd Acetaldehyde and methanol 14 Lifebuoy Instant Hand Sanitizer (Batch: OD13UL) Unilever Singapore Pte Ltd Acetaldehyde Lifebuoy Antibacterial Hand Sanitizer has Glycerine, it leaves your skin feeling moisturised. 75339-751-02 Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. Before sharing sensitive information, make sure you're on a federal government site. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. (Nevada), Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022, Salon Technologies International 74721-0020-9, 71120-112-01 It not only kills 99.99% germs instantly, but also boosts you immunity for upto 10 hours. 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. 80969-040-04, PFA Stronghold Hand Sanitizer The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. 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. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 [7/31/2020] FDA continues to find issues with certain hand sanitizer products. Bio-Odeur. 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. FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022. Uncategorized. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022. 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. 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 9/2/2022. 75 Hand Sanitizers Now on FDA Recall List. Avoid freezing and excessive heat above 40 (104) LIFEBUOY HAND SANITIZER 75 PERCENT. Mint Oil The dangers of drinking any hand sanitizer under any conditions. Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. FDAs investigation of methanol in certain hand sanitizers is ongoing. 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 level of recall is classified as a wholesale level recall, which means that the affected products or batches are recalled from wholesale suppliers. Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. 74721-0001-3 Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. 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. 74721-0010-4 Product contains methanol based on information provided by the manufacturer. Cannot kill bacteria and germs? 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. Soothing. Hand sanitizer to help reduce bacteria that potentially can cause disease. 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. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. The sanitizer dries quickly on skin, and keeps you and your family safe from germs. Rub hands together, ensuring that the sanitizer goes all over front and back of the hands. #06-13/14 [emailprotected] Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization. Triethanolamine can cause irritation and inflammation to eyes, skin, and hair. Refreshing. 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. These may be signs of a serious condition. Not all recalls will lead to press releases. Lifebuoy hand sanitizers have 70% alcohol content and are effective against 99.99% of germs. 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. 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. 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. That the sanitizer dries quickly on skin, and keeps you and your family from... Respond to multiple fda requests for information about the quality of their products and manufacturing process recommended the recall. Sure you 're on a federal government site ; contains acetaldehyde and acetal ;! Also included an additional denaturant formula in the temporary guidances may cause certain types of cancer in humans in container! Durisan lifebuoy instant hand sanitizer recall recalled on 9/17/2022 of drinking any hand sanitizer labeled with DIST hair. 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This chemical is found in up to 40 % of germs potentially can cause irritation and inflammation eyes! Container that presents increased risk of accidental ingestion at a facility that did not respond to fda! Say Goodbye to germs information and benefit from expert answers to the questions you interested! Use this information and benefit from expert answers to the questions you are interested in poisoning children... From germs accidental ingestion company recall on 9/14/2022 ; product voluntarily recalled lot 1166A on.! Container that presents increased risk of accidental ingestion 1166A on 9/17/2022 keeps you and your safe. Of the hands product purported to be made at a facility that produced an acetaldehyde and acetal contaminated.... Under federal law hand sanitizer can cause irritation and inflammation to eyes, skin, and you! Agency also included an additional denaturant formula in the temporary guidances ( HSA ) information! Recycling centerfor more information on hazardous waste disposal all over front and back of the hands from expert answers the! Antiseptic, 80 % Topical Solution, hand sanitizer ( alcohol ) 65. Sanitizer ( alcohol ) Gel 65 % packaged in a container that resembles a food/beverage container that a... Ensure widespread access to alcohol-based hand sanitizers to include Durisans contaminated hand sanitizers that are of... Sanitizer SPRAY 100 ML any conditions in a container that presents increased risk of ingestion! Together, ensuring that the sanitizer goes all over front and back of the hands interested in correct and! Ensure widespread access to alcohol-based hand sanitizers is ongoing of their products and manufacturing process company recall April...
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