Highest risk U.S. Food and Drug Administration

V-Klean, Medical Minded, Protz Hand Sanitizer recall: Potential presence of methanol (wood alcohol) and subpotent ethanol levels

Recall published 6+ years ago

Potential presence of methanol (wood alcohol) and subpotent ethanol levels

V-Klean, Medical Minded, Protz Prescription & OTC drugs — recalled prescription & otc drugsV-Klean, Medical Minded, Protz Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)V-Klean, Medical Minded, Protz Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)V-Klean, Medical Minded, Protz Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Harmful chemical exposure

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

What the notice says: 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: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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
August 25, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
V-Klean, Medical Minded, Protz
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
716053704993, 676753003782, 7503019005002

Products covered by this recall

Hand Sanitizer

What the company announced

Mexico City, Mexico, Asiaticon SA de CV (Mexico) is voluntarily recalling all lots of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer sold in 13.5, 16.9 and 33.8 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) and subpotent ethanol levels.

Risk Statement: Methanol has inferior antiseptic properties compared to ethanol. 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 person 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 Asiaticon SA de CV has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in plastic clear bottles with clear tops with UPC Code:

V-Klean in 8.5 fl. oz. (250 ml) bottles: 716053704993

V-Klean in 16.9 fl. oz. (500 ml) bottles: 716053704993

V-Klean in 33.8 fl. oz. (1000 ml) bottles: 716053704993

Medically Minded in 16.9 fl. oz. (500 ml) bottles: 676753003782

Protz in 13.5 fl. oz. (400 ml) bottles : 7503019005002

The recall includes all lots. This product was exported to different distributors nationwide.

Asiaticon SA de CV is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Asiaticon SA de CV per the below for disposal instructions or return it to the place of purchase.

Consumers with questions regarding this recall can contact Asiaticon SA de CV at [email protected] (0052 1 55 21553488). In the US: at 929 394 3020 (available Monday to Friday 9.30 am 6 pm eastern time) 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.

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 12 codes 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.

  • 716053704993
  • 676753003782
  • 7503019005002

Package size

Match the net weight or the piece count on the front of the pack.

  • 33.8 ounce
  • 8.5 fl. oz
  • 250 ml
  • 16.9 fl. oz
  • 500 ml
  • 33.8 fl. oz
  • 1000 ml
  • 13.5 fl. oz
  • 400 ml

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 Chemical

V-Klean, Medical Minded, Protz — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  3. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  4. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.

Remedy named in the notice: Consumers that have the product subject to this recall should stop using and either contact Asiaticon SA de CV per the below for disposal instructions or return it to the place of purchase.

Company contact: Asiaticon SA de CV — Consumers: Asiaticon SA de CV, 0052155 21553488, In the US: at 929 394 3020, [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 V-Klean, Medical Minded, Protz prescription & otc drugs recalled?

Potential presence of methanol (wood alcohol) and subpotent ethanol levels 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 716053704993, 676753003782, 7503019005002. 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?

Stop using the product and keep it away from children and pets.

Can I get my money back?

The notice says: Consumers that have the product subject to this recall should stop using and either contact Asiaticon SA de CV per the below for disposal instructions or return it to the place of purchase.

Where was the recalled product sold?

It was distributed nationwide.

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