Highest risk U.S. Food and Drug Administration

Saniderm Advanced Hand Sanitizer, 70% alcohol content recall: Potential presence of methanol (wood alcohol)

Recall published 6+ years ago

Potential presence of methanol (wood alcohol)

Saniderm Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

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
June 29, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Saniderm
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Advanced Hand Sanitizer, 70% alcohol content

What the company announced

UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-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, UVT, INC. has not received any reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in 1-liter plastic bottles. The affected SANIDERM ADVANCED HAND SANITIZER includes lot number 0530, Expiration date 04/2022. The product can be identified by the label below. Product was distributed Nationwide in the United States.

UVT, INC. is notifying its distributors and customers by phone calls, emails and letter and is arranging for replacement and destruction of all recalled products.

Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase. purchase.

Consumers with questions regarding this recall can contact UVT, INC. by phone (951) 427- 3108 or e-mail to [email protected] Monday to Friday from 9:00 am and 3:00 pm Pacific Time. 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.

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.

  • 0530

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 04/2022

Package size

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

  • 830 liters
  • 1 liter

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

Saniderm — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: UVT, INC. is notifying its distributors and customers by phone calls, emails and letter and is arranging for replacement and destruction of all recalled products.

Company contact: UVT, INC. — Consumers: UVT, INC., Nora Salazar, (951) 427-3108, [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 Saniderm 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: lot code 0530; best-by date 04/2022. 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: UVT, INC. is notifying its distributors and customers by phone calls, emails and letter and is arranging for replacement and destruction of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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