Elevated risk U.S. Food and Drug Administration

Yacana Hand Sanitizer, 70% Alcohol recall: Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol

Recall published 6+ years ago

Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol

Yacana Prescription & OTC drugs — recalled prescription & otc drugsYacana 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: Harmful chemical exposure

A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

What the notice says: Ethanol levels below the label claim can result in a lack of efficacy.

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 18, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Yacana
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Yacana Hand Sanitizer, 70% Alcohol

What the company announced

Guadalupe, Nuevo León, Grupo Yacana México S.A.S de C.V. is voluntarily recalling All Lots of Yacana Hand Sanitizer, 70% Alcohol, 250 ml to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.

Risk Statement: The use of sub-potent hand sanitizer products can have adverse health consequences related to infections. Ethanol levels below the label claim can result in a lack of efficacy. In addition, 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, your 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, Grupo Yacana Mexico S.A. de C.V. has not received any reports of adverse events related to this recall.

The product is used as a hand sanitizer to help reduce bacteria in hands and is packaged in 250 ml bottles, All lots (NDC: 76592-001-01) and All lots (NDC: 76592-002-04) The product can be identified by the label attached in this document. Hand Sanitizer was distributed Nationwide in the USA to Wholesale distributors.

Grupo Yacana México S.A.S de C.V. is notifying its distributors and customers by contacting them by email and sending a letter of Product Recall and is arranging for return of all recalled products. Distributors that have Hand Sanitizer which is being recalled should stop using and return to place of purchase.

Consumers with questions regarding this recall can contact Grupo Yacana México S.A.S de C.V. at 915-320-7016 or [email protected] on Monday through Friday from 9 am and 5 pm, CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

CDER’s press statement: 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 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 70

NDC number

On the carton and again on the bottle or blister label.

  • 76592-001-01
  • 76592-002-04

Package size

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

  • 250 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

Yacana — A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

  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.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.

Company contact: Grupo Yacana México S.A.S de C.V. — Consumers: Grupo Yacana México S.A.S de C.V., 915-320-7016

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 Yacana prescription & otc drugs recalled?

Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol Ethanol levels below the label claim can result in a lack of efficacy.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 70. 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?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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