Highest risk U.S. Food and Drug Administration

Gelbac T Antibacterial Handgel recall: Methanol Contamination

Recall published 6+ years ago

Methanol Contamination

Gelbac T Prescription & OTC drugs — recalled prescription & otc drugsGelbac T Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Gelbac T Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 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: Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and 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 6, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Gelbac T
Product type
Prescription & OTC drugs
Distribution
Delaware

Products covered by this recall

Antibacterial Handgel

What the company announced

INCREDIBLE PRODUCTS SA DE CV is voluntarily recalling 1 lot of GELBAC T ANTIBACTERIAL HANDGEL, packaged in 1 liter /33.8 oz plastic bottles and 125ml/4.2 oz plastic bottles of to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). FDA sampling of product at the port of entry to contain undeclared methanol.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and 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 an alcohol (ethanol) substitute are most at risk for methanol poisoning. To date, INCREDIBLE PRODUCTS SA DE CV has not received reports of adverse events related to this recall.

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected Hand Sanitizers are packaged in clear plastic bottles. The recalled products are as follows:

Product, Sizes and LOT:

GELBAC T ANTIBACTERIAL HANDGEL

Sizes 33.8 oz, 4.2 oz

LOT CODE 001

INCREDIBLE PRODUCTS SA DE CV is notifying its distributors and customers by recall letter and consumers via this press release and is arranging for refund of all recalled products.

Consumers with questions regarding this recall can contact INCREDIBLE PRODUCTS SA DE CV by sending an email to [email protected] and [email protected] during business hours.

Contact

Jesus Guillermo Vazquez Ramirez

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 5 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.

  • 001

Package size

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

  • 1 liter
  • 33.8 oz
  • 125 ml
  • 4.2 oz

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

Gelbac T — 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. Ventilate the room if the product was sprayed or applied there.
  3. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  4. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.

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.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • 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.

Remedy named in the notice: INCREDIBLE PRODUCTS SA DE CV is notifying its distributors and customers by recall letter and consumers via this press release and is arranging for refund of all recalled products.

Company contact: Incredible Products Sa de Cv — Consumers: INCREDIBLE PRODUCTS SA DE CV, [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 Gelbac T prescription & otc drugs recalled?

Methanol Contamination Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and 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: lot code 001. 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: INCREDIBLE PRODUCTS SA DE CV is notifying its distributors and customers by recall letter and consumers via this press release and is arranging for refund of all recalled products.

Which states were affected?

The notice lists Delaware.

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