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CLEVELAND -- Two months after the U.S. Food and Drug Administration (FDA) discovered that consumers across the country were unwittingly buying and using toxic hand sanitizers to combat the coronavirus, the agency is notifying the public about a completely different problem. Now, nearly two dozen sanitizers have been flagged for not containing enough active ingredients to kill the virus that causes COVID-19. And one has been detected to contain a substance possibly more toxic than methanol: It’s 1-propanol.
With these issues in mind, the FDA’s do-not-use list has expanded this week to about 100 brands and 150 varieties, including, for the first time, a sanitizer produced in China. Also added to the list in recent days were sanitizers manufactured in Ohio, Texas, Utah and North Carolina. Most of the other problematic brands were produced in Mexico.
To be effective, sanitizers should contain high percentages of either of two forms of alcohol -- at least 60 percent ethanol or 70 percent isopropanol -- that are safe on human skin, according to the Centers for Disease Control and Prevention.In the last 10 days, the FDA has identified 20 sanitizers that didn’t contain enough ethanol, isopropyl or another active ingredient to be effective.
Some of those sanitizers also contained methanol, another form of alcohol that is used to make fuel and antifreeze and is dangerous when absorbed through the skin (or inhaled or ingested). In mid-June, the FDA issued public alerts because five brands involving 19 varieties of hand sanitizer either contained methanol or were produced using equipment contaminated by methanol. The FDA reported a rash of illnesses and four deaths in the United States that it believes were connected to toxic hand sanitizers. The FDA’s ongoing investigation has found methanol contamination ranging from 1 percent to 80 percent in various sanitizers.
On Wednesday, the FDA flagged four varieties of sanitizer manufactured by Harmonic Nature because it was found to contain 1-propanol. That toxin can cause allergic reactions, nervous system problems and even death if it is absorbed through the skin, ingested or comes into contact with the eyes. The FDA on Wednesday asked the company to recall the products. Symptoms of 1-propanol exposure include confusion, slowed pulse and slowed breathing.
Most of the companies producing those dangerous sanitizers never registered before with the FDA to produce over-the-counter drugs. Hand sanitizer falls into that category with the FDA.
The brands called out by the FDA include: V-Klean, CleanCare, dgreen, Clean Humans, Datsen, Bernal, Inflatables Alcohol Antiseptic, Medically Minded, Protz, OZO, UltraCruz and Healthy Food and Nutrition Lab (HF&N).
One of the new brands on the list Tuesday was Leafree Instant Hand Sanitizer, manufactured by Yangzhou Olande Cosmetic Co. in China. The product was labeled “edible alcohol,” the FDA said. No sanitizers containing ethanol or isopropyl alcohol are intended for consumption. The FDA promptly put an import alert on it to stop it from entering the United States.
Consumers are urged to scrutinize any hand sanitizer they’ve bought since March, which is when the FDA relaxed its guidelines to allow unregistered companies to produce hand sanitizer.
The FDA says consumers shouldn’t use sanitizers from any of the named companies, even if the variety or lot numbers are different. Pay close attention to products manufactured in Mexico, products with no disclosure about where they were produced and products with names you’re not familiar with or that sound odd -- for example, simply, “Hand Sanitizer.”
“Manufacturers’ failure to immediately recall all potentially affected products is placing consumers in danger of methanol poisoning,” the FDA said. “Additionally, the FDA is strongly urging distributors and retailers to stop distributing and selling hand sanitizers manufactured by the firms on the list immediately, even if the particular product is not included in a recall, due to the risk of methanol poisoning.”
Consumers should continue to check for updates to the FDA’s list of dangerous products because its investigation is ongoing.
Consumers and health care professionals are encouraged to report issues with hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. People can:
Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Consumers, manufacturers or distributors who have questions can email the FDA at COVID-19-Hand-Sanitizers@fda.hhs.gov.
Anyone experiencing symptoms such as headache, blurry or impaired vision, nausea, vomiting, abdominal pain, loss of coordination or confusion and believes it’s connected to hand sanitizer can contact Poison Control at 1-800-222-1222 or your doctor.
Here’s the list of hand sanitizers the FDA has flagged as of Aug. 13 that should not be used:
Alcohol Antiseptic 62% Hand Sanitizer (Quimica Magna de Mexico)
Alcohol Antiseptic 75% Topical (Harmonic Nature)
Alcohol Antiseptic 80% topical (Botanicals Internacional)
All-Clean Hand Sanitizer (EskBiochem)
All Clear Hand Sanitizer (Botanicals Internacional)
Always Be Clean (Open Book Extracts, North Carolina)
AMX Instant Hand Sanitizer (Noticias Mexico Hoy Grupo Multimedia)
Andy’s (Limpo Quimicos)
Andy’s Best (Limpo Quimicos)
Antiseptic Alcohol 70% Topical Solution hand sanitizer (Soluciones Cosmeticas)
Anti-Bac Hand Sanitizer (Real Clean Distribuciones)
Assured (4E Global)
Assured (Albek de Mexico)
Be Safe (Tropicosmeticos)
Bernal (Quimica Magna)
Bersih (Soluciones Cosmeticas)
Bio AAA Advance (AAA Cosmetica)
Blumen (4E Global SAPI de CV)
Born Basic (Real Clean Distribuciones)
BV BYE Virus (Plastico Las Palmas)
Cavalry (Real Clean Distribuciones)
Clean Humans (DEPQ Internacional)
CleanCare NoGerm (Precision Analitica Integral)
CleanCare NoGerm (Eskbiochem)
Cleaner Hand (Tropicosmeticos)
Command Gel (Roque Plast)
DAESI hand sanitizer (Yara Elena De La Garza Perez Nieto)
Datsen (Quimica Magna)
Derma70 Hand Sanitizer (Asiaticon)
Dgreen (DEPQ Internaciona)
Earths Amenities (DDI Multinacional)
Enliven (Real Clean Distribuciones)
Esk Biochem (Eskbiochem)
Foamy iQ (Spartan Chemical)
GelBac (Incredible Products)
Good Gel (Eskbiochem)
Greenfrog Sanitizing Wipes (Notarika)
Hand Sanitizer (DEPQ Internacional)
Hand Sanitizer (Grupo Insoma)
Hand Sanitizer (Grupo Plast Y Kosas)
Hand Sanitizer (Incredible Products)
Hand Sanitizer (MXL Comercial)
Hand Sanitizer (Real Clean)
Hand Sanitizer (Soluciones Cosmeticas)
Hand Sanitizer Agavespa Skincare (DDI Multinacional)
Hand Sanitizer Disinfectant Gel (Resource Recovery & Trading)
Hello Kitty (4E Global)
HF&N (Healthy Food and Nutrition Lab)
Honeykeeper (4E Global)
In Good Hands (Plastico Las Palmas)
Inatek (Botanicals Internacional)
Incredible Products (Pacific Coast)
Jalisco (Grupo Plast)
Jaloma (Laboratorios Jaloma)
Just Hand Sanitizer Single-Use Packs (Open Book Extracts, North Carolina)
Klar and Danver (4E Global)
Leafree (Yangzhou Olande Cosmetic)
Leiper’s (Leiper’s Fork Distillery, Tennessee)
Lite'n Foamy by Roque Plast (Spartan Chemical Co Inc., Ohio)
LumiSkin (AAA Cosmetica)
Lux Eoi (Real Clean Distribuciones)
M Hand Sanitizer (Grupo Plast)
Medical Mary Clean (Noticias Mexico Hoy Grupo)
Medically Minded (Asiaticon)
Modesa (Albek de Mexico)
Mystic Shield Protection (Mystic International)
NeoNatural (Limpo Quimicos)
NEXT (Albek de Mexico)
NuuxSan (Albek de Mexico)
O.K. Pharmacy (Grupo Plast)
Optimus (Liqesa Exportacion)
OZO (Estrategia Hospitalaria)
OZO (Ismar Soluciones Dinámicas)
Plus Advanced (Limpo Quimicos)
Protz Real Protection Antibacterial (Asiaticon)
Purity (Soluciones Cosmeticas)
QualitaMed (AAA Cosmetica)
ResQue 1st (Botanicals Internacional)
Sayab (JG Atlas Comercios)
Scent Theory - Keep It Clean (Real Clean Distribuciones)
Selecto (Maquiladora Miniara)
70% Alcohol Gel Hand Sanitizer (Botanicals Internacional)
Shine and Clean Hand Sanitizer (Maquiladora Miniara)
SkinGuard24 All-Day (SG24 LLC, Georgia)
Total Pure (Botanicals Internacional)
TriCleanz (Tritanium Labs USA LLC, Illinois)
TriCleanz (Incredible Products)
UltraCruz (Santa Cruz Biotechnology, Texas)
Urbane Bath and Body (Tropicosmeticos)
Vidanos Easy Cleaning (DDI Multinacional)
Volu-Sol (Volu-Sol, Inc., Utah)
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