74530-012-03 Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 The sanitizer dries quickly on skin, and keeps you and your family safe from germs. Company tested product lot 2004090090; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. 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). 75 Hand Sanitizers Now on FDA Recall List. Click on link below to viewthe list of affected products (Annex A): Recall of hand sanitisers (Feb to April 2021)_Annex A486 KB, Bringing personal medications into Singapore, Controlled drugs and psychotropic substances, Medicines quality and compliance monitoring, Registration guides for therapeutic products, Healthcare professional, Industry member, Cosmetic products, Advertisements and promotions of medicinal products, Free Sales Certificate and Export Certificate, Bringing personal medical devices into Singapore, COVID-19: Standards Resources for Essential Medical Devices, Listing of approvals and post-registration actions, Apply for retention, cancellation or transfer application, Fees and Turnaround time of Chinese Proprietary Medicines, Good Manufacturing Practice certification for cosmetic products, Tobacco retailer educational video and quiz, Register of Licensed CTGTP Importers, Wholesalers and Manufacturers, Regulations for bringing in personal medications, Guidance for suppliers of hand sanitisers, Good Distribution Practice for Medical Devices, Summary Reports of Benefit-Risk Assessment, GMP conformity assessment of overseas manufacturers, Preparations allowed as General Sale List, Good Manufacturing Practice and Good Distribution Practice Standards, Handling of Applications and Conduct of Inspections During COVID-19, Renew or cancel a retail pharmacy licence, Supply of registered therapeutic products through e-pharmacy, Product Quality Surveillance for therapeutic products, Apply for a Chinese Proprietary Medicine dealer's licence, Amend a Chinese Proprietary Medicine dealer's licence, Good Manufacturing Practice and Good Distribution Practice, Import for re-export of Chinese Proprietary Medicines, Amend licence to wholesale or manufacture controlled drugs, Fluorescence in situ hybridisation (FISH) probes IVD, Class D with a registrable drug in a secondary role full registration, Class D with registrable drug in secondary role abridged registration, Import for re-export of unregistered devices, Unregistered devices for non-clinical purposes, Registered medical devices on consignment basis, Unregistered devices requested by qualified practitioners, Unregistered devices requested by licensed PHMC, Import of unregistered medical devices for exhibition, Import of unregistered pre-owned devices from maintenance/repair, PSAR for Supply of Emergency Medical Devices, Import and supply of unregistered TP for patient's use, Import and supply of registered drug on consignment basis, Special consignment by a product registrant, Pandemic Special Access Route for Supply of Emergency TP, Special Access Route for Unauthorised COVID-19 Vaccines, Full evaluation route for MAV-1 application, Abridged evaluation route for MAV-1 application, Verification evaluation route for MAV-1 application, Good Manufacturing Practice certificate for local manufacturers, Good Distribution Practice certificate for local dealers, Nitrosamine impurities in medicines- List of medicines impacted, Apply for tobacco import and wholesale licence, Amend tobacco import and wholesale licence, Renew tobacco import and wholesale licence, Cancel tobacco import and wholesale licence, Import and supply of unregistered Class 2 CTGTP, Import and supply of CTGTP on consignment basis, Recall of hand sanitisers (Feb to April 2021)_Annex A, Epi KleenGel Hand Sanitizer Gel (all batches), Guardian Lavender & Passion Flower Antibacterial Hand Sanitiser (Batch: 9K28DF), Guardian Aloe & Korean-Mint Antibacterial Hand Sanitiser (Batch: 0D32DF), Kundal Fresh Water Hand Sanitizer+ (Batch: BN227), Cool Day's Peppermint Instant Hand Sanitizer (all batches), Lifebuoy Instant Hand Sanitizer (Batch: OD13UL), FairPrice Hand Sanitiser Lavender (Batch: 201251-001), germ-X Advanced Hand Sanitizer Original Scent (all batches), Sanigen Gel Hand Refreshing Gel 600ml (all batches). Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol. 75821-002-03. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. Refreshing. 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. 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. Clinishield Instant Hand Sanitizer 70%; Stoko Gel Instant Hand Sanitizer 70%; Stoko Refresh Instant Hand Sanitizer 70%: Evonik Stockhausen Inc. Ethyl alcohol: Yes: Gel: 80023112: Instant Foaming Hand Sanitizer: Belvedere International Inc. Alcool dshydrat Yes: Foam: 80023535: Eo Hand Sanitizer: Small World Trading Company: Ethanol: Yes . Target's Born Basic and Walmart's Scent Theory bring the expanded list of recalled sanitizers to more than 75. 80969-007-01 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Need help now? 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): [1/19/2021] Today, FDA issued a guidance outlining the agencys 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. 74721-0002-1 71120-117-02, 75821-001-01 ], 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, 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; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, SBL Brands LLC dba Global Sanitizers LLC (Nevada), Alcohol Antiseptic 70% Solution or 80% Solution, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily, 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, TriCleanz (labeled with Made in Mexico), TriCleanz Tritanium Labs Hand Sanitizer (labeled with Made in Mexico), 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, 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, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to, Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinmicas 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, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, MVP Sanitizing Services Spray Hand Sanitizer, 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, Leipers Fork Distillery Bulk Disinfectant per 5 gallon and Leipers 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, 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, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to, 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, 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, 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, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily, 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, The Crme Shop Moisturizing Hand Sanitizer, Peppermint Scented, FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to, 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, Company tested product; contains methanol; product voluntarily recalled by, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily, 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, 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, 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, Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China), Best Brand Consumers Products, Inc. (New York), Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022;added manufacturer to, FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations, Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to, FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Noticias Mexico Hoy Grupo Multimedia (Mexico), 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, Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; added manufacturer to, Product purported to be made at the same facility that produced subpotent product; added manufacturer to, Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer, Real Clean Distribuciones SA de CV (Mexico), Born Basic.
Vw Tiguan Traction Control Button,
Articles L