https://www.cnn.com/2020/10/14/health/cottonelle-flushable-wipes-recall-trnd 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. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. The site is secure. October 13, 2020. The bacteria is fairly mild, but those with compromised immune systems may be at greater risk of a serious reaction. Companies Centers for Disease Control and Prevention, FDA Updates on Hand Sanitizers Consumers Should Not Use FDA. Seven new products were added to the list last week. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (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 FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. Do not pour these products down the drain or flush them. View the full list below or a detailed list which includes information about the manufacturer and reasoning behind a certain product recall on the FDA website. Consumer and health care professional safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply. In October 2020, Kimberly-Clark announced the recall of Cottonelle Flushable Wipes and GentlePlus Flushable Wipes due to the presence of pluralibacter gergoviae bacteria, which can lead to infection.The wipes have been in high demand due to the pandemic. 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). Personal care giant Kimberly-Clark has recalled specific lots of Cottonelle Flushable Wipes and Cottonelle GentlePlus Flushable Wipes manufactured between … Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 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. It is still recommended that you wash your hands often for at least 20 seconds and especially after going to the bathroom, before eating, and after coughing, sneezing, or blowing your nose. 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. Pluralibacter gergoviae bacteria is often found in soil, water, and sewage. To find recalls that affect products sold by Target: Online: See our product recalls in the drop downs below. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. Call Poison Help at 800-222-1222 to connect to your local poison center. For more information, visit Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? containers resembling food pouches labeled with children’s 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 children’s 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 recalled by Ashtel on 10/1/2020 (includes product photos), Lite ’n Foamy Lemon Blossom Hand Sanitizer, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020, Private D Capital Group Corp., Human Choice LLC and, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; product voluntarily recalled on 7/14/2020 and updated the recall on 8/9/2020; FDA issued a warning letter on 8/4/2020, Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020, 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 import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 8/4/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020, 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 import alert to help stop their products from entering the U.S. on 7/10/2020, Kleanz Antibacterial Hand Sanitizer Advanced, Be Safe Hand Sanitizer (labeled with “Model: BF-HGXXXX-09” where XXXX changes based on packaging size), 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 import alert to help stop their products from entering the U.S. on 7/10/2020; FDA has no evidence of U.S. distribution of Be Safe Hand Sanitizer manufactured by Tropicosmeticos, Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer, FDA tested product; contains methanol; FDA has been unable to determine the manufacturer or contact distributor to recommend a recall, 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 or contact distributor to recommend a recall, Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, 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 import alert to help stop their products from entering the U.S. on 7/17/2020, Product labeled to be “edible alcohol”; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA recommended a recall to the distributor on 9/1/2020; product voluntarily recalled by CorgioMed LLC on 9/3/2020. Kimberly-Clark recalls flushable wipes due to bacteria. The dangers of drinking any hand sanitizer under any conditions. Lot Number: Please see the attached list of impacted lot numbers. Mary Claire Patton has been a journalist with KSAT 12 since 2015. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. October 14, 2020. On the official product recall website, the brand listed Cottonelle Flushable Wipes and Cottonelle GentlePlus Flushable Wipes manufactured between Feb. 7 … 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. Kimberly-Clark, the manufacturer of Cottonelle Flushable Wipes and Cottonelle GentlePlus Flushable Wipes, said on its website that the recall is limited to "specific lots" that were manufactured between Feb. 7, 2020, and Sept. 14, 2020. Is being recalled by the manufacturer or distributor. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. The FDA says the recalled hand sanitizer products are considered unsafe due to methanol contamination or because they contain “concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products.”. 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 alcohol’s source. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. The affected products were sold from February 14, 2020 to October 7, 2020. The recall is limited to specific lots of Cottonelle® Flushable Wipes and Cottonelle® GentlePlus Flushable Wipes manufactured between February 7, 2020 – September 14, 2020… According to a recall notification sent to Canadian customers Friday, the 10 pack of wipes were sold between Feb. 14th, 2020 and Oct. 8th, 2020. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s 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. If you purchased these wipes from Costco between Feb. 14 and Oct. 8, 2020, you should not use them and return them for a full Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. 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). (Gray News) - Cottonelle has issued a recall of certain packages of their Cottonelle Flushable Wipes and Cottonelle GentlePlus Flushable Wipes after reports of … Cottonelle Flushable Wipes, also sold by Costco, had to be recalled this year due to the discovery of possible microbial activity, according to a statement from manufacturer Kimberly-Clark. [1/19/2021] Today, FDA issued a guidance outlining the agency’s 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. You … ; In Target Stores: Visit the iPads at Guest Services or the iPads at in-aisle Help Centers in select stores. The agency will provide additional information as it becomes available. Learn more at poisonhelp.hrsa.gov/. Billed as having the “texture and the cleansing power of water to deliver long-lasting freshness,” the affected products include Cottonelle Flushable Wipes and Cottonell GentlePlus Flushable wipes manufactured between February 7, 2020, and September 14, 2020, and could contain the bacterium Pluralibacter gergoviae, the company announced Friday. However, consistent with FDA’s 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. Has been tested by FDA and found to contain methanol or 1-propanol. 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 FDA’s temporary guidances. Notice to manufacturers and distributors: If you believe your products do not meet the criteria for inclusion on this list, please provide your reasoning and supporting information for our consideration to HSDoNotUseListInquiries@fda.hhs.gov . Previously, officials with the FDA have said they were aware of reports of adverse events associated with the listed hand sanitizer products including adults and children who ingested products contaminated with methanol that led to blindness, hospitalizations and death. Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA. The recall of antiseptic wipes comes more than a year after a massive recall of swabs, wipes and other products made and distributed by sister … Heads up, coronavirus hoarders: Cottonelle Flushable Wipes have just been recalled due to a potential bacterial contamination. Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? Has been tested and is found to have microbial contamination. For more products that have been recently recalled, keep reading. Place of origin. Hand Sanitizer Industrial and Hospital Grade, Guangzhou Youxing Cosmetics Co. Ltd.(China), V&W Advance Hand Sanitizer Refreshing Gel, FDA tested product; ethanol alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020, Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020, V&W Moisturizing Refreshing Spray Sanitizer, 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 import alert to help stop their products from entering the U.S. on 8/20/2020; product voluntarily recalled on 8/14/2020; FDA issued a warning letter on 11/16/2020, 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; ethanol alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020, FDA tested product; ethanol alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/3/2020, Product purported to be made at the same facility that producted subpotent ethanol alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/3/2020, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/21/2020; FDA issued a warning letter on 1/25/2021, Alcohol Antiseptic 70% Solution or 80% Solution, 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 import alert to help stop their products from entering the U.S. on 8/21/2020; FDA issued a warning letter on 1/25/2021, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily recalled on 8/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020, 71761-000-01 71761-000-05 71761-000-10 71761-000-20 71761-000-22 71761-000-37 71761-000-99, 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 import alert to help stop their products from entering the U.S. on 8/13/2020, 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 import alert to help stop their products from entering the U.S. on 9/14/2020, 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 import alert to help stop their products from entering the U.S. on 9/14/2020, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethanol alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020, Product purported to be made at the same facility that produced subpotent ethanol alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 10/2/2020, Hand Sanitizer Isopropyl Alcohol Antiseptic 75%, Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinámicas 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 import alert to help stop their products from entering the U.S. on 8/14/2020, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/2020, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/7/2020; FDA issued a warning letter on 11/6/2020, MVP Sanitizing Services Spray Hand Sanitizer, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 9/1/2020, 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 recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/3/2020; FDA issued a warning letter on 1/25/2021, Leiper’s Fork Distillery Bulk Disinfectant per 5 gallon and Leiper’s 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 import alert to help stop their products from entering the U.S. on 7/15/2020, 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 import alert to help stop their products from entering the U.S. on 7/15/2020, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020, 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 import alert to help stop their products from entering the U.S. on 7/15/2020; product voluntarily recalled on 7/20/2020; FDA issued a warning letter on 11/19/2020, 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 import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 11/19/2020, 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 import alert to help stop their products from entering the U.S. on 7/15/2020; product voluntarily recalled on 7/20/2020; FDA issued a warning letter on 11/19/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily recalled on 7/9/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020, 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 import alert to help stop their products from entering the U.S. on 7/16/2020, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/24/2020; product voluntarily recalled on 7/27/2020; FDA issued a warning letter on 11/10/2020, 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 import alert to help stop their products from entering the U.S. on 7/24/2020; product voluntarily recalled on 7/27/2020; FDA issued a warning letter on 11/10/2020, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/27/2020, Company tested product; contains methanol; product voluntarily recalled by Transliquid Technologies LLC on 7/2/2020, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily recalled on 8/26/2020; added manufacturer to import alert (66-78) to help stop their products from entering the U.S. on 8/31/2020; added to import alert (66-40) on 1/12/2021, 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 recalled on 8/26/2020; added manufacturer to import alert (66-78) to help stop their products from entering the U.S. on 8/31/2020; added to import alert (66-40) on 1/12/2021, 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 import alert to help stop their products from entering the U.S. on 9/18/2020, 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 import alert to help stop their products from entering the U.S. on 9/18/2020, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020, 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 import alert to help stop their products from entering the U.S. on 8/11/2020, Noticias Mexico Hoy Grupo Multimedia (Mexico), 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 import alert to help stop their products from entering the U.S. on 8/21/2020, 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 import alert to help stop their products from entering the U.S. on 8/21/2020, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/29/2020, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to import alert to help stop their products from entering the U.S. on 8/6/2020, 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 import alert to help stop their products from entering the U.S. on 8/6/2020, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethanol alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/5/2021, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethanol alcohol level was subpotent; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a warning letter on 10/15/2020, Product purported to be made at the same facility that produced subpotent product; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a warning letter on 10/15/2020, Real Clean Distribuciones SA de CV (Mexico), Born Basic.
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