More. Click on each ingredient to learn more. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. Hand Sanitizer Company Announcement San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. 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. [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. The agency continues to add certain hand sanitizers to the import alert to stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law. Polysaccharides which derive from the inner filet of Aloe Vera, optimizes absorption that is vital to delivering the moisturizing benefits of aloe vera to your skin! 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). Best hand sanitizers 2020 that meet CDC requirements, according to medical doctors and are in stock now. Continuing the Lily motto "Retaining the Quality that Nature Created," Lily becomes the largest U.S. grower and processor of aloe vera products in the natural products industry in 1991. Safety. 99 ($0.37/Fl Oz) Get it as soon as Fri, Feb 12. Restaurant Supplies Hand Sanitizer, FDA tested product; ethanol 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 import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/2021, Yacana Alcohol Antiseptic 70% Topical Solution, FDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/2021, 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 recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/2021, 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 recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/2021, Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China), FDA tested product; contains methanol; product voluntarily recalled by Shane Erickson on 12/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the manufacturer recall on 1/25/2020, Guangdong Kemei Pharmaceutical Technology Co. Ltd, Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020, KLEAN KARE Hand Sanitizer Industrial and Hospital Grade, Essentials, M.D. Is being recalled by the manufacturer or distributor. Label RSS; Share Bookmark & Share. The FDA is asking customers to safely dispose of the sanitizer in question (view full lists here and here). MANUFACTURING CAPABILITIES We offer innovative solutions to bring your products to life. We also have pumps for the gallons to purchase by request if you need one of those. Inclusion on this list does not constitute an endorsement by Health Canada. 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. FRESH LAVENDER SCENT. LILY OF THE DESERT HAND SANITIZER – with Aloe Vera Get rid of Germs without sacrificing your skin our clean formula has a 70% ethyl alcohol base plus our own soothing, organically-grown Aloe vera. VIEW MORE. The FDA says using non-approved hand sanitizers could be deadly. FDA Home; Medical Devices; Databases - The information on this page is current as of April 1 2020. $17.99 $ 17. In this guidance FDA provide the formulation and labeling for hand sanitizer manufacturer. Consumers should be aware that FDA’s recommendation against using a distributor’s 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. SKU: 35ml. Derived from RSPO palm oil and non-GMO rapeseed oil, glycerin is a rich humectant, emollient and lubricant which allows moisturizers to draw and absorb water from the air helping skin retain moisture. COLD BREW Whether it’s coffee or tea, ready-to-drink […] NUTRITION DIVISION Great tasting and convenient supplements for many of your health needs! Derma70 Hand Sanitizer. Touchland, CBD for Life, Germ-X and more on Amazon. FDA’s investigation of methanol in certain hand sanitizers is ongoing. KEEPING HANDS HEALTHY & HAPPY. USP’s 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. Founded in 1971, Lily of the Desert is privately owned and operated by the Lovelace Family headquartered in Denton, Texas. View Package Photos. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). The FDA doesn't allow hand sanitizer brands to make claims about efficacy against contracting viruses, such as any stating that Purell hand sanitizers are effective against the flu. Shop. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. 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. A judge ordered a Lake Forest hand sanitizer company to stop claiming its products can protect against specific diseases without federal approval after the owners of Purell filed a … CFR - Code of Federal Regulations Title 21. 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). The .gov means it’s official.Federal government websites often end in .gov or .mil. 75432-001-02. To date, there are no hand sanitizers in Canada approved with COVID-19 related claims. FDA’s final rule made triclosan (another popular ingredient) as ineligible for the purpose of hand sanitizer. Unlike sanitizers (discussed below), cleaners and detergents are designed to be rinsed off, and a subsequent rinse step is sufficient to prevent contamination of organic foods from synthetic cleaner residues. Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol or 1-propanol. Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Alcohol (70%) Ethyl alcohol is derived from corn … FDA reminds consumers to 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 one’s nose. For questions, contact FDA:  COVID-19-Hand-Sanitizers@fda.hhs.gov. FDA issued a guidance on March 2020 with temporary policy for manufacturing of hand sanitizer products during covid-19 pandemic. Looking for our Aloe Products? Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Centers for Disease Control and Prevention (CDC) COVID-19. Desert Harvest hand sanitizer should be for sale online soon. 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. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use. Toilet Paper. Don’t worry about the long name, this is just a simple thickener! Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Has been tested and is found to have microbial contamination. Mirah Belle - Lily Hand Wash - FDA Approved - Natural, Vegan, Cruelty Free - Best for Men, Women and Family - Sulfate and Paraben Free: Amazon.in: Health & Personal Care Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA updates on hand sanitizers consumers should not use, 1/26/2021: PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers, 1/19/2021: UPDATE - FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency, 8/27/2020 PRESS RELEASE - COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers, 8/24/2020: UPDATE – FDA provides testing method to assess the quality of hand sanitizer products for impurities, 8/12/2020: UPDATE - FDA expands hand sanitizer warnings to include 1-propanol contamination, local waste management and recycling center, Centers for Disease Control and Prevention, 8/7/2020:  UPDATE - FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers, 7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products, 7/27/2020 PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products, 7/2/2020: UPDATE - FDA warns consumers of risk of methanol contamination in certain hand sanitizers, 7/2/2020 PRESS RELEASE - FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, 6/19/2020 ALERT - FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem. Ethanol used to manufacturer hand sanitizer products under FDA’s temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. Learn more at poisonhelp.hrsa.gov/. FDA … The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. Made with naturally-derived alcohol, Dove Hand Sanitizer is 99.99% effective against many common germs and meets FDA required alcohol levels. ORGANIC ALOE QUALITY: Lily of the Desert hand sanitizer contains 30 times the Aloe content than the leading competitor and it is Organic Aloe. 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). ALCOHOL BASED (70%) MADE WITH 15% ALOE. 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. Welcome to Lily of the Desert We are excited to launch our new corporate website! Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. 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). 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. 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 FDA’s temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. 2. Anti-Bac Hand Sanitizer 70% 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 7/16/2020; product voluntarily recalled on 7/23/2020; FDA issued a warning letter on 10/27/2020, Born Basic. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Drug Label Info. Click on each ingredient to learn more. EO Organic Hand Sanitizer Spray: French Lavender, 6 count . KILLS HARMFUL BACTERIA & GERMS. 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. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Bulk Hand Sanitizer. 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 import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020, 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 recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020, 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 import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/11/2020; FDA issued a warning letter on 10/23/2020, 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 import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020, 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; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020, 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 recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020, BLUMEN Advanced Instant Hand Sanitizer Lavender, 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 recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020, 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), 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 import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers, 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, 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 import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers, FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; product voluntarily recalled on 7/14/2020; FDA issued a warning letter on 2/3/2021, 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 import alert to help stop their products from entering the U.S. on 7/7/2020; product voluntarily recalled on 9/3/2020; FDA issued a warning letter on 2/3/2021, 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 import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/2021, FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020, 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 recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020, 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 import alert to help stop their products from entering the U.S. on 9/2/2020, 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 import alert to help stop their products from entering the U.S. on 9/2/2020, FDA tested product; ethanol alcohol level was subpotent; 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 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020, Product purported to be made at the same facility that produced subpotent ethanol alcohol 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 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/2020, DermX70 Hand Sanitizer (only includes 250mL, 500mL and, Product purported to be made at the same facility that produced subpotent ethanol alcohol 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 8/11/2020; FDA issued a warning letter on 10/29/2020, Protz Real Protection Antibacterial 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 import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/2021, Inatek Hand Sanitizer Non-Sterile Solution, 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 8/13/2020; FDA issued a warning letter on 2/3/2021, Total Pure Alcohol Based Hand Sanitizer Gel, Herbacil Antiseptic Hand Sanitizer 70% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/2020, 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 recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/2020, 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 10/9/2020, Soho Fresh Hand Sanitizer Gel Antibacterial, FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/2020, 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 import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/2020, Product voluntarily recalled by Essaar Inc. due to methanol contamination on 1/4/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/2020, 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 on all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/2020, FDA tested product; contains methanol; FDA recommended the company recall on other all potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/2020, 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 on all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/2020, 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 import alert to help stop their products from entering the U.S. on 7/31/2020, 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 import alert to help stop their products from entering the U.S. on 7/31/2020, Distribuidora Lagunera del Norte SA de CV, FDA tested product; ethanol alcohol level was subpotent; FDA has no evidence this product is in the U.S. market, 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.