FDA Expands Warning on Methanol-Tainted Hand Sanitizers
From AARP
FDA Expands Warning on Methanol-Tainted Hand Sanitizers
Deaths, blindness tied to toxic ingredient found in imported sanitizers
by Peter Urban, Updated July 9, 2020
The U.S. Food and Drug Administration (FDA) is warning consumers to stop using 55 hand sanitizer products from 10 manufacturers in Mexico that may contain methanol, which can be toxic when absorbed through the skin or ingested.
The FDA has seen a “sharp increase” in tainted hand sanitizers since first issuing a consumer alert in June for nine products made by Eskibiochem that had tested positive for methanol. Five more products were added to the FDA warning last week.
The FDA says it is aware of adults and children who have recently died, been blinded or hospitalized after ingesting hand sanitizer products contaminated with methanol, also known as wood alcohol.
"Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. The FDA's investigation of methanol in certain hand sanitizers is ongoing,” the FDA said in a statement.
In Arizona, 16 people who were hospitalized in June for toxic alcohol exposure admitted to drinking hand sanitizer. Six others suspected of doing the same also were hospitalized but denied drinking hand sanitizer, according to the Arizona Poison and Drug Information Center.
"No amount of methanol should be found in hand sanitizers. Methanol can be extremely toxic, which is why we are seeing such an increase in hospitalizations,” said the center's director Steve Dudley, in a statement.
The New Mexico Department of Health also issued a statement last month warning that three people died and one person was blinded from methanol poisoning after drinking hand sanitizer. In all, seven people drank hand sanitizer containing methanol, according to the release, which was based on cases reported to the New Mexico Poison Control and Drug Information Center over several weeks in May.
If you have purchased any of the 55 hand sanitizers listed in the warning, the agency recommends you stop using them immediately and dispose of the hand sanitizer in “appropriate hazardous waste containers.” Do not flush them down the toilet or pour them down the drain, the FDA advises.
Transliquid Technologies, one of the subjects of the recent FDA safety alert, issued a voluntary recall on July 2 of all Mystic Shield Protection hand sanitizer packaged in 8.45 ounce (250-milliliter) bottles. The firm's independent testing confirmed the presence of methanol. Mystic Shield Protection hand sanitizer was distributed between May 21 and June 30 to select wholesale and retail customers in California, Louisiana, Massachusetts and Texas. Consumers with questions regarding this recall can contact Transliquid Technologies by phone at 281-377-5845 or by email at memob@transliquidtechnologies.com.
Symptoms of methanol exposure
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, according to the FDA.
The Centers for Disease Control and Prevention (CDC) says that it can take between one hour and three days for adverse health effects from methanol poisoning to become apparent. It also cautions that methanol toxicity worsens over time, and adverse effects can become more severe if left untreated.
"Initial adverse health effects due to methanol poisoning include drowsiness, a reduced level of consciousness (central nervous system depression), confusion, headache, dizziness and the inability to coordinate muscle movement (ataxia). Other adverse health effects may include nausea, vomiting (emesis), and heart and respiratory (cardiopulmonary) failure,” according to the CDC.
In response to COVID-19, the FDA reminds people to wash their hands using 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) to prevent the spread of the coronavirus. If soap and water is not available, the CDC suggests using a hand sanitizer that contains at least 60 percent ethanol to kill most disease-causing germs. Anything less than that may not work as well “for many types of germs,” and could “merely reduce the growth of germs rather than kill them outright,” the CDC says.
Hand sanitizer works best when used correctly. Be sure to apply enough hand sanitizer to cover the entire surface of both hands. Rub the hand sanitizer into your hands (paying special attention to the fingertips) until your skin is completely dry; it should take about 20 seconds.
55 Hand Sanitizers Subject to FDA Safety Warning
*National Drug Code (NDC) is a unique identifier assigned to drug products, including hand sanitizers.
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FDA Expands Warning on Methanol-Tainted Hand Sanitizers
Deaths, blindness tied to toxic ingredient found in imported sanitizers
by Peter Urban, Updated July 9, 2020
The U.S. Food and Drug Administration (FDA) is warning consumers to stop using 55 hand sanitizer products from 10 manufacturers in Mexico that may contain methanol, which can be toxic when absorbed through the skin or ingested.
The FDA has seen a “sharp increase” in tainted hand sanitizers since first issuing a consumer alert in June for nine products made by Eskibiochem that had tested positive for methanol. Five more products were added to the FDA warning last week.
The FDA says it is aware of adults and children who have recently died, been blinded or hospitalized after ingesting hand sanitizer products contaminated with methanol, also known as wood alcohol.
"Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. The FDA's investigation of methanol in certain hand sanitizers is ongoing,” the FDA said in a statement.
In Arizona, 16 people who were hospitalized in June for toxic alcohol exposure admitted to drinking hand sanitizer. Six others suspected of doing the same also were hospitalized but denied drinking hand sanitizer, according to the Arizona Poison and Drug Information Center.
"No amount of methanol should be found in hand sanitizers. Methanol can be extremely toxic, which is why we are seeing such an increase in hospitalizations,” said the center's director Steve Dudley, in a statement.
The New Mexico Department of Health also issued a statement last month warning that three people died and one person was blinded from methanol poisoning after drinking hand sanitizer. In all, seven people drank hand sanitizer containing methanol, according to the release, which was based on cases reported to the New Mexico Poison Control and Drug Information Center over several weeks in May.
If you have purchased any of the 55 hand sanitizers listed in the warning, the agency recommends you stop using them immediately and dispose of the hand sanitizer in “appropriate hazardous waste containers.” Do not flush them down the toilet or pour them down the drain, the FDA advises.
Transliquid Technologies, one of the subjects of the recent FDA safety alert, issued a voluntary recall on July 2 of all Mystic Shield Protection hand sanitizer packaged in 8.45 ounce (250-milliliter) bottles. The firm's independent testing confirmed the presence of methanol. Mystic Shield Protection hand sanitizer was distributed between May 21 and June 30 to select wholesale and retail customers in California, Louisiana, Massachusetts and Texas. Consumers with questions regarding this recall can contact Transliquid Technologies by phone at 281-377-5845 or by email at memob@transliquidtechnologies.com.
Symptoms of methanol exposure
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, according to the FDA.
The Centers for Disease Control and Prevention (CDC) says that it can take between one hour and three days for adverse health effects from methanol poisoning to become apparent. It also cautions that methanol toxicity worsens over time, and adverse effects can become more severe if left untreated.
"Initial adverse health effects due to methanol poisoning include drowsiness, a reduced level of consciousness (central nervous system depression), confusion, headache, dizziness and the inability to coordinate muscle movement (ataxia). Other adverse health effects may include nausea, vomiting (emesis), and heart and respiratory (cardiopulmonary) failure,” according to the CDC.
In response to COVID-19, the FDA reminds people to wash their hands using 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) to prevent the spread of the coronavirus. If soap and water is not available, the CDC suggests using a hand sanitizer that contains at least 60 percent ethanol to kill most disease-causing germs. Anything less than that may not work as well “for many types of germs,” and could “merely reduce the growth of germs rather than kill them outright,” the CDC says.
Hand sanitizer works best when used correctly. Be sure to apply enough hand sanitizer to cover the entire surface of both hands. Rub the hand sanitizer into your hands (paying special attention to the fingertips) until your skin is completely dry; it should take about 20 seconds.
55 Hand Sanitizers Subject to FDA Safety Warning
- BLUMEN Advanced Instant Hand Sanitizer Clear, manufactured by 4E Global, SAPI de CV (*NDC: 60599-015-00, 60599-015-01, 60599-015-02)
- Blumen Clear Advanced Hand Sanitizer with 70% Alcohol, manufactured by 4E Global, SAPI de CV (No NDC listed)
- Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%, manufactured by 4E Global, SAPI de CV (No NDC listed)
- KLAR AND DANVER Instant Hand Sanitizer (labeled with Greenbrier International Inc.), manufactured by 4E Global, SAPI de CV (NDC: 33992-8010-1)
- MODESA Instant Hand Sanitizer Moisturizers and Vitamin E, manufactured by 4E Global, SAPI de CV (NDC: 60599-007-33)
- BLUMEN Advanced Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-012-00, 60599-012-01, 60599-012-02, 60599-012-03, 60599-012-04, 60599-012-05, 60599-012-06, 60599-012-07, 60599-012-08, 60599-012-10)
- BLUMEN Advanced Hand Sanitizer Aloe, manufactured by 4E Global, SAPI de CV (NDC: 60599-013-00, 60599-013-01, 60599-014-00)
- BLUMEN Advanced Instant Hand Sanitizer Lavender, manufactured by 4E Global, SAPI de CV (NDC: 60599-016-00)
- BLUMEN Clear LEAR Advanced Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-017-00, 60599-017-01, 60599-018-00, 60599-018-01)
- BLUEMEN Clear Advanced Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-018-02, 60599-018-03, 60599-018-04, 60599-018-05, 60599-018-06, 60599-018-07, 60599-018-08, 60599-019-00)
- The Honeykeeper Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-020-00, 60599-020-01)
- BLUMEN Advanced Hand Sanitizer Clear, manufactured by 4E Global, SAPI de CV (NDC: 60599-024-00)
- BLUMEN Clear Advanced Instant Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-025-00)
- BLUMEN Clear Advanced Instant Hand Sanitizer Aloe, manufactured by 4E Global, SAPI de CV (NDC: 60599-026-00)
- BLUMEN Clear Advanced Instant Hand Sanitizer Lavender, manufactured by 4E Global, SAPI de CV (NDC: 60599-027-00)
- BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol, manufactured by 4E Global, SAPI de CV (NDC: 60599-028-00, 60599-029-00)
- Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol, manufactured by 4E Global, SAPI de CV (NDC: 60599-046-00)
- Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol, manufactured by 4E Global, SAPI de CV (NDC: 60599-047-00)
- Blumen Antibacterial Fresh Citrus Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-501-01)
- Blumen Hand Sanitizer Fresh Citrus, manufactured by 4E Global, SAPI de CV (NDC: 60599-502-01)
- KLAR and DANVER INSTANT HAND SANTIZER, manufactured by 4E Global, SAPI de CV (NDC: 60599-801-00)
- Hello Kitty by Sanrio Hand Sanitizer, manufactured by 4E Global, SAPI de CV (NDC: 60599-802-00)
- Assured Instant Hand Sanitizer (Vitamin E and Aloe), manufactured by 4E Global, SAPI de CV (NDC: 60599-850-00)
- Assured Instant Hand Sanitizer (Aloe and Moisturizers), manufactured by 4E Global, SAPI de CV (NDC: 60599-851-00)
- Assured Instant Hand Sanitizer Vitamin E and Aloe, manufactured by 4E Global, SAPI de CV (NDC: 60599-852-00)
- Assured Instant Hand Sanitizer Aloe and Moisturizers, manufactured by 4E Global, SAPI de CV (NDC: 60599-853-00)
- BLUMEN Instant Hand Sanitizer Fragrance Free, manufactured by 4E Global, SAPI de CV (NDC: 60599-854-00)
- BLUMEN Instant Hand Sanitizer Aloe Vera, manufactured by 4E Global, SAPI de CV (NDC: 60599-855-00)
- Assured Aloe, manufactured by 4E Global, SAPI de CV (NDC: 60599-999-10)
- bio aaa Advance Hand Sanitizer, manufactured by AAA Cosmetica (NDC: 76987-402-01)
- LumiSkin Advance Hand Sanitizer 4 oz, manufactured by AAA Cosmetica (NDC: 76987-120-01)
- LumiSkin Advance Hand Sanitizer 16 oz, manufactured by AAA Cosmetica (NDC: 76987-402-02)
- QualitaMed Hand Sanitizer, manufactured by AAA Cosmetica (NDC: 76987-250-01)
- Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced, manufactured by DDI Multinacional SA de CV (NDC: 74949-002-20, 74949-002-25, 74949-002-49, 74949-002-60)
- Hand Sanitizer Agavespa Skincare, manufactured by DDI Multinacional SA de CV (NDC: 77415-000-00)
- Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare, manufactured by DDI Multinacional SA de CV (NDC: 77056-000-01)
- All-Clean Hand Sanitizer, manufactured by Eskbiochem SA de CV (NDC: 74589-002-01)
- Esk Biochem Hand Sanitizer, manufactured by Eskbiochem SA de CV (NDC: 74589-007-01)
- Lavar 70 Gel Hand Sanitizer, manufactured by Eskbiochem SA de CV (NDC: 74589-006-01)
- The Good Gel Antibacterial Gel Hand Sanitizer, manufactured by Eskbiochem SA de CV (NDC: 74589-010-10)
- CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, manufactured by Eskbiochem SA de CV (NDC: 74589-005-03)
- CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol, manufactured by Eskbiochem SA de CV (NDC: 74589-009-01)
- CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, manufactured by Eskbiochem SA de CV (NDC: 74589-003-01)
- Saniderm Advanced Hand Sanitizer, manufactured by Eskbiochem SA de CV (NDC: 74589-001-01)
- Hand sanitizer Gel Unscented 70% Alcohol, manufactured by Grupo Insoma, S.A.P.I de CV (NDC: 75744-0200-3, 75744-0200-4, 75744-0201-5, 75744-0202-1, 75744-0250-1, 75744-0250-2, 75744-0500-1, 75744-1000-1, 75744-1000-3, 75744-1001-1)
- Andy’s Best, manufactured by Limpo Quimicos SA de CV (NDC: 73755-120-01, 73755-120-02, 73755-120-04)
- Andy’s, manufactured by Limpo Quimicos SA de CV (NDC: 73755-110-01, 73755-130-02)
- Gelclor, manufactured by Limpo Quimicos SA de CV (NDC: 73755-140-01)
- NeoNatural, manufactured by Limpo Quimicos SA de CV (NDC: 73755-200-01, 73755-200-02)
- Plus Advanced, manufactured by Limpo Quimicos SA de CV (NDC: 73755-300-01)
- Optimus Lubricants Instant Hand Sanitizer, manufactured by Liqesa Exportacion or Liq-E-S.A. de CV (NDC: 75416-004-01, 75416-005-01)
- Bersih Hand Sanitizer Gel Fragrance Free, manufactured by Soluciones Cosmeticas SA de CV (NDC: 75165-003-02, 75165-004-01, 75165-005-01, 75165-006-01, 75165-008-01, 75165-250-01, 75165-600-01)
- Antiseptic Alcohol 70% Topical Solution hand sanitizer, manufactured by Soluciones Cosmeticas SA de CV (No NDC listed)
- Mystic Shield Protection hand sanitizer, manufactured by Transliquid Technologies (NDC: 75477-435-02, 75477-435-10, 75477-435-12, 75477-435-25, 75477-435-50, 75477-534-10)
- Britz Hand Sanitizer Ethyl Alcohol 70%, manufactured by Tropicosmeticos SA de CV (NDC: 76676-402-01, 77676-402-02, 77676-402-03, 77676-402-04, 77676-402-05, 77676-402-06, 77676-402-07, 77676-402-08, 77676-402-09, 77676-402-10, 77676-402-11, 77676-402-12, 77676-402-13, 77676-402-14, 77676-402-16, 77676-402-17, 77676-402-18, 77676-402-19, 77676-402-2
*National Drug Code (NDC) is a unique identifier assigned to drug products, including hand sanitizers.
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Click title for article This entry was originally posted at https://thnidu.dreamwidth.org/1818365.html. You can comment here, or there using OpenID or your Dreamwidth ID.
comments there so far.