|
FDA Broadens Warning on Methanol-Tainted Hand Sanitizers
Deaths, blindness tied to toxic ingredient found in these sanitizers
GETTY IMAGES
En español | The U.S. Food and Drug Administration (FDA) is warning consumers to stop using 94 hand sanitizer products from 17 manufacturers in Mexico and one in Tennessee that may contain methanol, which can be toxic when absorbed through the skin or ingested.
Since first issuing a consumer alert in June for nine products made by Eskbiochem, the FDA has expanded its warning list and also placed the hand sanitizers on an import alert to help prevent the tainted products from entering the United States. A warning letter has also been issued to Eskbiochem regarding improper manufacturing methods, misleading claims of FDA approval, and failing to disclose methanol content on labels.
The FDA says they continue to see a rising number of "adverse events" associated with the tainted hand sanitizers — including death, blindness, and heart and nervous system complications — that have primarily been reported to poison control centers and state departments of health.
"We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated," FDA Commissioner Stephen M. Hahn, M.D., said in a statement.
Save 25% when you join AARP and enroll in Automatic Renewal for first year. Get instant access to discounts, programs, services, and the information you need to benefit every area of your life.
The FDA is urging consumers not to use any hand sanitizer products from the 16 Mexican and one U.S. manufacturers on the warning list, even if the product or particular lot number is not listed, since some manufacturers are recalling only certain — but not all — of their hand sanitizer products.
The listed manufacturers from Mexico are: Eskbiochem, 4E Global, AAA Cosmetica , Albek de Mexico, Broncolin, DDI Multinacional, Grupo Insoma, Laboratorios Jaloma, Limpo Quimicos, Liqesa Exportacion (or Liq), Maquiladora Miniara, MXL Comercial, Mystic International, Real Clean Distribuciones, Soluciones Cosmeticas, Tropicosmeticos, and Yara Elena De La Garza Perez Nieto. Also, there's Leiper's Fork Distillery, a U.S. manufacturer in Tennessee.
The American Association of Poison Control Centers (AAPCC) emphasizes that the FDA's warning "is not merely a cautionary note."
"Methanol has a long history of severe toxicity and led to the term "blind drunk" because of its potential to damage the optic nerve. There have been historical outbreaks of poisoning both from ingesting methanol, but most importantly from topical administration of substances containing methanol. This is especially concerning for children as they have a much higher surface area to weight ratio and are more likely to become sick from a topically applied poison than adults," the AAPCC said in a statement.
If you have purchased any of the 94 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, a distributor of 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 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) 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.
94 Hand Sanitizers Subject to FDA Safety Warning
1. All-Clean Hand Sanitizer, manufactured by Eskbiochem (National Drug Code (NDC): 74589-002-01)
2. Andy's Best, manufactured by Limpo Quimicos (NDC: 73755-120-01, 73755-120-02, 73755-120-04)
3. Andy's, manufactured by Limpo Quimicos (NDC: 73755-110-01, 73755-130-02)
4. Antiseptic Alcohol 70% Topical Solution hand sanitizer, manufactured by Soluciones Cosmeticas (NDC: Not listed)
5. Assured Aloe, manufactured by 4E Global (NDC: 60599-999-10)
6. Assured Instant Antiseptic Hand Sanitizer With Aloe and Moisturizers, manufactured by Albek de Mexico (NDC: 72758-009-23)
7. Assured Instant Antiseptic Hand Sanitizer With Vitamin E and Aloe, manufactured by Albek de Mexico (NDC: 72758-010-23)
8. Assured Instant Hand Sanitizer (Aloe and Moisturizers), manufactured by 4E Global (NDC: 60599-851-00)
9. Assured Instant Hand Sanitizer (Vitamin E and Aloe), manufactured by 4E Global (NDC: 60599-850-00)
10. Assured Instant Hand Sanitizer Aloe and Moisturizers, manufactured by 4E Global (NDC: 60599-853-00)
11. Assured Instant Hand Sanitizer Vitamin E and Aloe, manufactured by 4E Global (NDC: 60599-852-00)
12. Be Safe Hand Sanitizer, manufactured by Tropicosmeticos (NDC: 76676-402-16 - 76676-402-19)
13. Bersih Hand Sanitizer Gel Fragrance Free, manufactured by Soluciones Cosmeticas (NDC: 75165-000-01, 75165-001-01, 75165-003-02, 75165-004-01, 75165-005-01, 75165-006-01, 75165-008-01, 75165-250-01, 75165-600-01)
14. Bio AAA Advance Hand Sanitizer, manufactured by AAA Cosmetica (NDC: 76987-402-01)
15. Blumen Advanced Hand Sanitizer Aloe, manufactured by 4E Global (NDC: 60599-013-00, 60599-013-01, 60599-014-00)
16. Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol, manufactured by 4E Global (NDC: 60599-047-00)
17. Blumen Advanced Hand Sanitizer Clear, manufactured by 4E Global (NDC: 60599-024-00)
18. Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol, manufactured by 4E Global (NDC: 60599-046-00)
19. Blumen Advanced Hand Sanitizer, manufactured by 4E Global (NDC: 60599-012-04, 60599-012-08)
20. Blumen Advanced Hand Sanitizer, manufactured by 4E Global (NDC: 60599-012, 00 60599-012-01, 60599-012-02, 60599-012-03, 60599-012-05, 60599-012-06, 60599-012-07, 60599-012-10)
21. Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%, manufactured by 4E Global (NDC: Not listed)
22. Blumen Advanced Instant Hand Sanitizer Clear, manufactured by 4E Global (NDC: 60599-015-00)
23. Blumen Advanced Instant Hand Sanitizer Clear, manufactured by 4E Global (NDC: 60599-015-01, 60599-015-02)
24. Blumen Advanced Instant Hand Sanitizer Lavender, manufactured by 4E Global (NDC: 60599-016-00)
25. Blumen Aloe Advanced Hand Sanitizer, with 70% alcohol, manufactured by 4E Global (NDC: 60599-028-00)
26. Blumen Aloe Advanced Hand Sanitizer, with 70% alcohol, manufactured by 4E Global (NDC: 60599-029-00)
27. Blumen Antibacterial Fresh Citrus Hand Sanitizer, manufactured by 4E Global (NDC: 60599-501-01)
28. Blumen Clear Advanced Hand Sanitizer, with 70% alcohol, manufactured by 4E Global (NDC: Not listed)
29. Blumen Clear Advanced Hand Sanitizer, manufactured by 4E Global (NDC: 60599-017-00, 60599-018-00, 60599-018-01, 60599-018-02, 60599-018-04, 60599-018-06, 60599-018-07)
30. Blumen Clear Advanced Hand Sanitizer, manufactured by 4E Global (NDC: 60599-018-02, 60599-018-04, 60599-018-06, 60599-018-07)
31. Blumen Clear Advanced Instant Hand Sanitizer Aloe, manufactured by 4E Global (NDC: 60599-026-00)
32. Blumen Clear Advanced Instant Hand Sanitizer Lavender, manufactured by 4E Global (NDC: 60599-027-00)
33. Blumen Clear Advanced Instant Hand Sanitizer, manufactured by 4E Global (NDC: 60599-025-00)
34. Blumen Clear LEAR Advanced Hand Sanitizer, manufactured by 4E Global (NDC: 60599-017-00, 60599-018-01)
35. Blumen Clear LEAR Advanced Hand Sanitizer, manufactured by 4E Global (NDC: 60599-017-01, 60599-018-00, 60599-018-03, 60599-018-05, 60599-018-08, 60599-019-00)
36. Blumen Hand Sanitizer Fresh Citrus, manufactured by 4E Global (NDC: 60599-502-01)
37. Blumen Instant Hand Sanitizer Aloe Vera, manufactured by 4E Global (NDC: 60599-855-00)
38. Blumen Instant Hand Sanitizer Fragrance Free, manufactured by 4E Global (NDC: 60599-854-00)
39. Born Basic Anti-Bac Hand Sanitizer 65% Alcohol, manufactured by Real Clean Distribuciones (NDC: 76891-105-11 - 76891-105-20)
40. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol, manufactured by Real Clean Distribuciones (NDC: 76891-104-11 - 76891-104-19, 73389-104-11)
41. Britz Hand Sanitizer Ethyl Alcohol 70%, manufactured by Tropicosmeticos (NDC: 76676-402-01, 76676-402-02, 76676-402-14)
42. Cavalry, manufactured by Real Clean Distribuciones (NDC: 75460-070-01, 75460-070-02, 75460-070-05, 75460-075-38, 75460-080-38)
43. CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol, manufactured by Eskbiochem (NDC: 74589-009-01)
44. CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, manufactured by Eskbiochem (NDC: 74589-003-01)
45. CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, manufactured by Eskbiochem (NDC: 74589-005-03)
46. Cleaner Hand Sanitizer Rinse Free 70%, manufactured by Tropicosmeticos (NDC: 76676-402-07, 76676-402-08)
47. Clear Advanced Hand Sanitizer With 70% Alcohol, Extra Soft With Glycerin and Aloe, manufactured by Albek de Mexico (NDC: not listed)
48. Daesi Hand Sanitizer, manufactured by Yara Elena De La Garza Perez Nieto (NDC: 77268-001-01)
49. Earths Amenities Instant Unscented Hand Sanitizer With Aloe Vera Advanced, manufactured by DDI Multinacional (NDC: 74949-002-20, 74949-002-25, 74949-002-49, 74949-002-60)
50. Enliven Hand Sanitizing Gel, manufactured by Real Clean Distribuciones (NDC: 74882-341-01, 74882-341-02, 74882-341-03)
51. Esk Biochem Hand Sanitizer, manufactured by Eskbiochem (NDC: 74589-007-01)
52. Hand Sanitizer AgaveSpa Skincare, manufactured by DDI Multinacional (NDC: 77415-000-00)
53. Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub, manufactured by MXL Comercial (NDC: 77106-001-01, 77106-001-02, 77106-001-03, 77106-001-04, 77106-001-05, 77106-001-06, 77106-001-07, 77106-001-08)
54. Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, manufactured by MXL Comercial (NDC: 77106-002-01)
55. Hand Sanitizer Gel Alcohol 70%, manufactured by Soluciones Cosmeticas (NDC: 79095-000-01, 79095-001-01, 79095-002-01, 79095-003-01, 79095-004-01, 79095-005-01, 79095-006-01)
56. Hand Sanitizer Gel Unscented 70% Alcohol, manufactured by Grupo Insoma (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)
57. Handzer Hand Sanitizer Rinse Free, manufactured by Tropicosmeticos (NDC: 76676-402-10, 76676-402-11)
58. Hello Kitty Hand Sanitizer, manufactured by 4E Global (NDC: 60599-802-00)
59. Herbacil Antiseptic Hand Sanitizer 70% Alcohol, manufactured by Broncolin (NDC: 62583-020-08)
60. Herbacil Antiseptic Hand Sanitizer 70% Alcohol, manufactured by Broncolin (NDC: 62583-020-16, 62583-020-33, 62583-020-42)
61. Herbacil Antiseptic Hand Sanitizer 70% Alcohol, manufactured by Broncolin (NDC: 74673-001-08, 74673-001-16, 74673-001-33, 74673-001-42)
62. Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% With Vitamin E, manufactured by Laboratorios Jaloma, (NDC: 65055-600-00, 65055-600-01, 65055-600-02)
63. Klar and Danver Instant Hand Sanitizer (labeled with Greenbrier International Inc.), manufactured by 4E Global (NDC: 33992-8010-1)
64. Klar and Danver Instant Hand Sanitizer, manufactured by 4E Global (NDC: 60599-801-00)
65. Kleanz Antibacterial Hand Sanitizer Advanced, manufactured by Tropicosmeticos (NDC: 76676-402-05, 76676-402-06, 76676-402-12, 76676-402-13)
66. Lavar 70 Gel Hand Sanitizer, manufactured by Eskbiochem (NDC: 74589-006-01)
67. Leiper's Fork Distillery Bulk Disinfectant per 5 gallon and Leiper's Fork Distillery 16 oz. bottle, manufactured by Leiper's Fork Distillery (Tennessee) (NDC: Not Listed)
68. LumiSkin Advance Hand Sanitizer 16 oz., manufactured by AAA Cosmetica (NDC: 76987-402-02)
69. LumiSkin Advance Hand Sanitizer 4 oz., manufactured by AAA Cosmetica (NDC: 76987-120-01)
70. Lux Eoi Hand Sanitizing Gel, manufactured by Real Clean Distribuciones (NDC: 74882-007-01, 74882-007-02, 74882-007-03)
71. Modesa Instant Antiseptic Hand Sanitizer With Moisturizers and Aloe Vera, manufactured by Albek de Mexico (NDC: 72758-011-23)
72. Modesa Instant Antiseptic Hand Sanitizer With Moisturizers and Vitamin E, manufactured by Albek de Mexico (NDC: 72758-012-23)
73. Modesa Instant Hand Sanitizer Moisturizers and Vitamin E, manufactured by 4E Global (NDC: 60599-007-33)
74. Mystic Shield Protection Hand Sanitizer, manufactured by Mystic International (NDC: 75477-435-02, 75477-435-10, 75477-435-12, 75477-435-25, 75477-435-50, 75477-534-10)
75. NeoNatural, manufactured by Limpo Quimicos (NDC: 73755-200-01, 73755-200-02)
76. Next Hand Sanitizer, manufactured by Albek de Mexico (NDC: 50066-605-08)
77. NuuxSan Instant Antibacterial Hand Sanitizer, manufactured by Albek de Mexico (NDC: 72758-001-08, 72758-002-08)
78. NuuxSan Instant Hand Sanitizer, manufactured by Albek de Mexico (NDC: 72758-003-00, 72758-003-01, 72758-005-01, 72758-005-02, 72758-005-03)
79. Optimus Instant Hand Sanitizer, manufactured by Liqesa Exportacion or Liq (NDC: 75416-002-01, 75416-001-04, 75416-378-04)
80. Optimus Instant Hand Sanitizer, manufactured by Liqesa Exportacion or Liq (NDC: 75416-004-01)
81. Optimus Lubricants Instant Hand Sanitizer, manufactured by Liqesa Exportacion or Liq (NDC: 75416-005-01)
82. Parabola Hand Sanitizer, manufactured by Tropicosmeticos (NDC: 76676-402-03, 76676-402-09)
83. Plus Advanced, manufactured by Limpo Quimicos (NDC: 73755-300-01)
84. QualitaMed Hand Sanitizer, manufactured by AAA Cosmetica (NDC: 76987-250-01)
85. Saniderm Advanced Hand Sanitizer, manufactured by Eskbiochem (NDC: 74589-001-01)
86. Scent Theory Keep It Clean Pure Clean Anti-bacterial Hand Sanitizer, manufactured by Real Clean Distribuciones (NDC: 73389-102-11)
87. Scent Theory Keep It Clean Pure Clean Antibacterial Hand Sanitizer, manufactured by Real Clean Distribuciones (NDC: 76891-102-11)
88. Selecto Hand Sanitizer, manufactured by Maquiladora Miniara (NDC: 76753-002-01)
89. Shine and Clean Hand Sanitizer, manufactured by Maquiladora Miniara (NDC: 76753-001-01, 76753-001-02, 76753-001-03)
90. The Good Gel Antibacterial Gel Hand Sanitizer, manufactured by Eskbiochem (NDC: 74589-010-10)
91. The Honeykeeper Hand Sanitizer, manufactured by 4E Global (NDC: 60599-020-00, 60599-020-01)
92. Urbane Bath and Body Hand Sanitizer, manufactured by Tropicosmeticos (NDC: 76676-402-04)
93. Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare, manufactured by DDI Multinacional (NDC: 77056-000-01)
94. Wave Hand Sanitizer Gel, manufactured by Tropicosmeticos (NDC: 76676-402-20)
Editor's note: This story has been updated on July 31, 2020.
More on Health
- 7 things to know about hand sanitizer
- Dangerous misuse of bleach, disinfectants widespread in pandemic
- Are face shields better than masks for coronavirus protection?
|
Posts
No comments:
Post a Comment