Highest risk U.S. Food and Drug Administration

All Clean Hand sanitizer recall: Potential presence of methanol (wood alcohol)

Recall published 6+ years ago

Potential presence of methanol (wood alcohol).

All Clean Prescription & OTC drugs — recalled prescription & otc drugsAll Clean Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

What the notice says: Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 6, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
All Clean
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
628055370130

Products covered by this recall

Hand sanitizer

What the company announced

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure 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 accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning To date ITECH 361 has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and moisturizer and is packaged in one (1) liter plastic bottles with UPC Code 628055370130. All Clean Hand Sanitizer and Moisturizer was distributed Nationwide to wholesale distributors and retailers.

ITECH 361 is notifying its distributors by a Notice of a voluntary recall and consumers via this press release. ITECH 361 is arranging for return/replacement or refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using All Clean Hand Sanitizer, Moisturizer and Disinfectant and return it to the place of purchase.

Consumers with questions regarding this recall can contact Corina Enriquez by phone number (888)405-4442 or e-mail at [email protected] , Monday through Friday beginning July 6, 9:00a.m. to 5:00 p.m. (MDT). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA updates on hand sanitizers consumers should not use

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 628055370130

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

All Clean — This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: ITECH 361 is arranging for return/replacement or refund of all recalled products.

Company contact: ITECH 361 — Consumers: Corina Enriquez, (888)405-4442, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was All Clean prescription & otc drugs recalled?

Potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 628055370130. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: ITECH 361 is arranging for return/replacement or refund of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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