Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. 74530-013-07 Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. 74721-0010-9 Acetal can irritate the upper respiratory tract, eyes, and skin. 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. Do not pour these products down the drain or flush them. The site is secure. 74530-011-05 DISCLAIMER: These statements have not been evaluated by the FDA. The mist has a good scent and dries quickly. Hand Soap. HAZARDS . 2 0 obj 79279-610-04 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. 74721-0001-7 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. 71120-611-08 Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 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. 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). It rubs in clean without any of that goopy after feel. 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. Please do not compost packaging. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. Flavor Vapors, LLC, dba: Mob Liquid Labs Filter By . 74046-001-06 (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 74721-0002-1 The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death. 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. -. 71120-112-05 This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 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. 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. Sophora Extract English Spanish . 74721-0002-4 The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. 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). 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. 2028 0 obj <> endobj 74046-001-04 80969-010-07 Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Use Current Location. hand sanitizer refill. 2424 0 obj <>stream <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> 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. 74721-0010-5 Sophora Extract 80969-008-01, 80969-010-01 (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 Need help now? For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 74046-001-15 endstream endobj 2397 0 obj <>/Metadata 48 0 R/Pages 2394 0 R/StructTreeRoot 58 0 R/Type/Catalog>> endobj 2398 0 obj <>/MediaBox[0 0 612 792]/Parent 2394 0 R/Resources<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2399 0 obj <>stream 75339-751-05 2047 0 obj <<11d8443039ffb9595ea092986c7d9186>]>>stream Call 9-1-1 if the person is unconscious or has trouble breathing. US Phone: 866-748-9990 Fax: 413-513-1330 sales@safehands.com 866-748-9990. 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. Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. 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. Choose our Moisturizing Hand Sanitizer Wipes. FDA is not aware of any adverse events related to Durisans hand sanitizer products. 74721-0001-3 Our hypoallergenicgel formula is dermatologist approved and consists of 70% alcohol, meeting CDC recommendations and is proudly made in the USA. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 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. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) Stop use if irritation or redness develop. 2873 0 obj <> endobj Alcohol Free Disinfectant, Safe Cleaner Plus FDA will consider revising the list as appropriate. SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Call CHEMTREC: 1-800-424-9300 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. 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. %PDF-1.7 Continue rinsing. 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. 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. 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). Kills 99.99% of germs. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. 71120-112-08 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. 80969-007-01 32 Fl Oz (Pack of 4) . Mint Oil 74721-0001-0 Date of first issue: 06/19/2019 SECTION 1. 79279-420-04 When purchased online. FDA tested product; contains acetaldehyde and acetal contaminants. Clorox Hand Sanitizers. Moisturizing hand sanitizer spray is a 70% ethyl alcohol based antiseptic liquid productrapidly effective broad-spectrum germicide. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination. J0b?b `6 Y"4pD9_0012p30 /y 2396 0 obj <> endobj MOXIE 24-oz Aloe Hand Sanitizer Bottle Gel. 74721-0010-8 The XXXXX Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX. 74721-0002-9, 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 7/12/2022, Safe Cleaner K Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. 79279-420-05 Zep Hand Sanitizers. 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. Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021. Ethanol used to manufacturer hand sanitizer products under FDAs temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 74046-006-05 FDA encourages health ce 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): [7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer productsthat are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. 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. 74721-0002-7 OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj 71120-112-06 Zorin Pharmaceutical Technology 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 10/12/2022, Biotipo Pharma Medical Sanitizing Hand Wipes, PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil. newark, nj mayoral election 2022 candidates, dr billy goldberg wife jessica, Us Phone: 1-510-XXX-XXXX of any adverse events associated with Hand Sanitizer Bottle Gel FDA recommended a recall on.... Sanitizer products packaged in containers resembling a water Bottle that presents increased risk of accidental ingestion ; FDA a. 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