Assured, Blumen & Modesa Hand Sanitizer Recall [US]


Blumen Hand Sanitizer Recall [US]

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US FlagUS/Silver Spring: 4e Brands North America, a San Antonio, Texas establishment, recalls all current batch/lots of Assured, Blumen and Modesa branded Hand Sanitizer products from the American marketplace due to the suspected presence of Methanol (also called Methyl Alcohol or “Wood Alcohol”), with consequential risk of poisoning, oral injury, internal ingestion, GI tract laceration damage, blindness and death, all serious health and safety hazards requiring immediate medical intervention.

FDA: http://ht.ly/Fadl30r1V42

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/4e-brands-north-america-issues-expanded-nationwide-voluntary-recall-hand-sanitizer-due-potential

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Hand Sanitizer products are subject to this recall:

  • Assured Aloe Hand Sanitizer, sold in 8 fluid ounce (236 ml) bottles with a UPC of 639277490704
  • Assured Clear Hand Sanitizer, sold in 8 fluid ounce (236 ml) bottles with a UPC of 639277490698
  • Assured Aloe Hand Sanitizer, sold in 10 fluid ounce bottles with a UPC of 639277490704
  • Assured Clear Hand Sanitizer, sold in 10 fluid ounce bottles with a UPC of 639277490698
  • Blumen Advanced Clear Hand Sanitizer, sold in 2 fluid ounce bottles with a UPC of 814266023716
  • Blumen Aloe Advanced Hand Sanitizer, sold in 3.4 fluid ounce bottles with a UPC of 814266023587
  • Blumen Advanced Hand Sanitizer, sold in 3.4 fluid ounce bottles with a UPC of 814266023594
  • Blumen Advanced Hand Sanitizer, sold in 7.5 fluid ounce (221 ml) bottles with a UPC of 814266023624
  • Blumen Advanced Clear Hand Sanitizer, sold in 7.5 fluid ounce bottles with a UPC of 814266023624
  • Blumen Advanced Hand Sanitizer, sold in 7.5 fluid ounce (221 ml) bottles with a UPC of 814266023624
  • Blumen Advanced Hand Sanitizer, sold in 15.2 fluid ounce bottles with a UPC of 814266023921
  • Blumen Advanced Clear Hand Sanitizer, sold in 17 fluid ounce bottles with a UPC of 814266024096
  • Blumen Advanced Clear Hand Sanitizer, sold in 17 fluid ounce bottles with a UPC of 814266024096
  • Blumen Clear Hand Sanitizer, sold in 18 fluid ounce bottles with a UPC of 814266023914
  • Blumen Clear Tea Tree Hand Sanitizer, sold in 18 fluid ounce bottles with a UPC of 814266024089
  • Blumen Advanced Hand Sanitizer, sold in 33.8 fluid ounce bottles with a UPC of 814266023693
  • Blumen Advanced Clear Hand Sanitizer, sold in 33.8 fluid ounce bottles with a UPC of 814266023693
  • Blumen Advanced Clear Hand Sanitizer, sold in 33.8 fluid ounce bottles with a UPC of 814266023693
  • Blumen Advanced Clear Tea Tree Hand Sanitizer, sold in 33.8 fluid ounce bottles with a UPC of 814266023747
  • Blumen Advanced Clear Hand Sanitizer, sold in 70 fluid ounce bottles with a UPC of 814266023679
  • Blumen Advanced Clear Hand Sanitizer, sold in 1.05 gallon bottles with a UPC of 814266023686
  • Modesa Clear Gel Antibacterial 33.8 fluid ounce bottles with a UPC of 032251499357

Please consult the photograph above for details of the product’s packaging, design and retail presentation. Additional images of the recalled Hand Sanitizer products can be found on the Web site above.

==> No item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

According to the FDA, in response to a recent news alert by the Food and Drug Administration advising Americans of potentially toxic Hand Sanitizer products manufactured by at least one Mexican drug manufacturer, this product has been withdrawn from the US marketplace.

Consumption of Methanol/Methyl Alcohol can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as if they were consuming Ethanol (i.e., drinking alcohol) as a substitute, are most at risk for Methanol poisoning.

==> Never depend on your senses of sight, smell, taste or touch to confirm poisoning, adulteration or contamination. If in doubt about the safety of any product, return it to your retailer for refund, making sure neither small children nor household pets can access the suspect product.

If you believe you have purchased or have in your possession any of the recalled Assured, Blumen and Modesa branded Hand Sanitizer products, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Hand Sanitizer products to the store where you purchased it for a full refund.

Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect the drinking water supply and the ecosystem. Do not dispose of this product through your household sewer system. Instead, consult with your local pharmacist or municipal waste authority for disposal instructions.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat Methanol poisoning.

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US CDC Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact 4e Brands North America LLC toll-free at 1-888-843-0254 from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday or by e-mail at 4EBrands8797@stericycle.com, quoting Event 8797.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Hand Sanitizer, please search for “hand sanitizer” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Methanol contamination, please search for “methanol” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by 4e Brands North America LLC, please search for “4e Brands” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 13314-2020
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