New and expanded recalls, ‘toxic’ methanol list additions: a hand sanitizer update
WEDNESDAY MORNING UPDATE: Another recall has been added.
A hand sanitizer company that supplied Walmart, Costco and other stores pulled three brands from the U.S. market. Two other companies recalled hand sanitizer. The FDA’s do-not-use-it-has-methanol list has its first U.S. company.
And the first company on that list got an FDA warning letter saying, in part, stop claiming their hand sanitizer was “FDA Approved.”
The most recent recalls and yet another broad FDA warning about hand sanitizer with methanol hit email boxes Monday evening.
That followed last week’s recall of five hand sanitizers, two of which were sold at Walmart and Target.
As hand sanitizers reappeared on shelves three months into the COVID-19 pandemic, the FDA began targeting hand sanitizers with methanol (wood alcohol) — “a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested,” the agency said.
(An FDA spokesman confirmed Tuesday that each of the eight hand sanitizer-methanol deaths the agency knows of came from people ingesting hand sanitizer.)
The Latest Recalls
The July 12 recall of Blumen hand sanitizer, which touched Walmart and Costco, got expanded by 4e Brands North America to all lots of these hand sanitizers:
▪ Assured Clear, 8 ounces and 10 ounces.
▪ Assured Aloe, 8 ounces and 10 ounces.
▪ Blumen Advanced, 3.4 ounces, 7.5 ounces, 15.2 ounces, 33.8 ounces.
▪ Blumen Advanced Clear, 2 ounces, 7.5 ounces, 17 ounces, 33.8 ounces, 70 ounces, 1.05 gallons.
▪ Blumen Aloe Advanced, 3.4 ounces.
▪ Blumen Clear, 18 ounces.
▪ Blumen Clear Tea Tree, 18 ounces.
▪ Blumen Advanced Clear Tea Tree, 33.8 ounces.
▪ Modesa Clear Gel Antibacterial, 33.8 ounces.
If you have these hand sanitizers, return them to the store for a full refund. People with questions can call 888-843-0254, Monday through Friday, 8 a.m. to 8 p.m., Eastern time.
Resource Recovery & Trading pull all lots of its hand sanitizers made by MXL Comercial. These :
▪ Hand Sanitizer 70% Ethyl Alcohol Disinfectant Gel, 6.7-ounce bottles.
▪ Hand Sanitizer Non-sterile Solution 70% Topical Solution, 20-liter jugs.
Same as above, return these products to the seller from whence they came for a full refund. If you have questions, email admin@rr-t.net or call 858-964-4590, Monday through Friday, noon to 6 p.m., Eastern time.
▪ In a recall posted to the FDA site Tuesday night, Brocolin recalled all lots of its Herbacil Antiseptic Hand Sanitizer 70% Alcohol. It comes in 125 ml, 250 ml, 500 ml and 1-liter bottles. It was distributed nationwide by wholesalers in Florida, California, Texas, North Carolina, South Carolina, Georgia, Illinois, Arizona, Maryland, New Jersey and New York.
For questions about this recall, email handsanitizer@inbctrading.com or call INBC Trading at 512-241-9034, Monday through Friday, 9 a.m. to 6 p.m.
Contact a medical professional if you feel ill from using the hand sanitizer. Then, report it on the adverse event part of the FDA’s website or by calling the agency at 800-332-1088.
The FDA’s Do-Not-Use List Additions
While the above recalls cover eight brands made by 4e Global, the company has 35 of the 87 entries on the FDA’s list of hand sanitizers that tested as having methanol or were believed to be made in the same facility.
In the middle of Monday’s warning, the FDA said it’s “urging consumers not to use any hand sanitizer products from the particular manufacturers on the list even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products.”
▪ Broncolin’s Herbacil Antiseptic Hand Sanitizer 70% Alcohol tested positive for methanol, the FDA said.
▪ Laboratorios Jaloma’s Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E tested positive for methanol.
▪ Testing wasn’t necessary for either Tennessee-made Leiper’s Fork Distillery Bulk Disinfectant, 5 gallons or Leiper’s Fork Distillery, 16-ounce bottles. The FDA says methanol is listed on the label.
The Warning Letter
The above list started with nine products made by Eskbiochem. While individual distributors have recalled Saniderm made by Eskbiochem, the manufacturer itself resists the FDA’s requests for a mass pulling of product.
So, the FDA put Eskbiochem’s hand sanitizers on an import alert list on July 15 to keep them out of the county, then sent a Warning Letter on Thursday.
In addition to repeating the methanol claims, the FDA didn’t cotton to “FDA Approved” appearing on the brsupply.com website to which the Lavar Gel Hand Sanitizer label refers; or on the label of ClearCare Nogerm Advanced Hand Sanitizer.
This story was originally published July 28, 2020 at 5:12 PM with the headline "New and expanded recalls, ‘toxic’ methanol list additions: a hand sanitizer update."
