Highest risk U.S. Food and Drug Administration

Nuuxsan, Modesa, more Hand Sanitizer recall: Undeclared Methanol

Recall published 6+ years ago

Undeclared Methanol

Nuuxsan, Modesa, more Prescription & OTC drugs — recalled prescription & otc drugsNuuxsan, Modesa, more Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Nuuxsan, Modesa, more Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Nuuxsan, Modesa, more 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: 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 could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) 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 31, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Nuuxsan, Modesa, more
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
713620000175, 639277928597, 639277928610
Reports of harm
To date, there have been no reports of serious adverse events related to the products in the scope of this recall.

Products covered by this recall

Hand Sanitizer

What the company announced

SAN JUAN del RIO QUERETARO, Mexico -- ALBEK de Mexico S.A. de C.V. is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. The products were manufactured between November 7, 2019 and June 28, 2020.

This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product was presented for import into the United States.

Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death. Persons using methanol-based products on their hands may be at risk. Young children who accidently ingest them and adolescents and adults who drink such products are most at risk for methanol poisoning. To date, there have been no reports of serious adverse events related to the products in the scope of this recall.

Recalled Products: The products are labeled for use as a hand sanitizer (or “antiseptic”) and are packaged for several nationwide distributors in a variety of formats as indicated in the table as follows:

  • BRANDS:: Product Name · Nuuxsan: Nuuxsan Instant Hand Sanitizer · Modesa: Modesa Hand Sanitizer with Moisturizers and Aloe Vera · Assured: Assured Hand Sanitizer Vitamin E and Aloe · Assured: Assured Hand Sanitizer Aloe Vera · Next: Next Hand Sanitizer
  • BRANDS:: NDC · Nuuxsan: 72758-005-02, 72758-001-08 · Modesa: 72758-011-23 · Assured: 72758-010-23 · Assured: 72758-009-23 · Next: 50066-605-08
  • BRANDS:: Sizes · Nuuxsan: 8 fl oz · Modesa: 8 fl oz · Assured: 8 fl oz · Assured: 8 fl oz · Next: 8 fl oz
  • BRANDS:: UPC · Nuuxsan: 713620000175 · Modesa: 32251380426 · Assured: 639277928597 · Assured: 639277928610 · Next: 650240053573
  • BRANDS:: Affected Lots · Nuuxsan: All Lot #s · Modesa: 1931104AL · Assured: 1931101AL · Assured: 1931102AL · Next: The affected lots end in: 1001, 1002, 1003, 1004, 1005

These products were distributed nationwide in the United States beginning on November, 15 2019.

Albek is partnering with its distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled products. Consumers, distributors, and retailers that have product which is being recalled should stop use or distribution and return to place of purchase.

Consumers with questions regarding this recall can contact Albek de Mexico S.A. de C.V. during the business hours business hours: 9:00am – 5:00pm (CT)

Email: [email protected]

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products.

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.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 713620000175
  • 639277928597
  • 639277928610

Package size

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

  • 8 fl 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 Allergen

Nuuxsan, Modesa, more — 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. If someone does avoid it, stop serving it and check anything already cooked with it.
  3. Warn anyone else who eats from your kitchen, including schools and childminders.
  4. Report any reaction to the FDA so it is recorded against this recall.

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.

Company contact: ALBEK de Mexico S.A. de C.V. — Consumers: Albek de Mexico S.A. de C.V., (713)961-0262, [email protected] — Media: Manuel Beltrán M., 52 1 427 101 8200 ext. 102

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 Nuuxsan, Modesa, more prescription & otc drugs recalled?

Undeclared Methanol Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 713620000175, 639277928597, 639277928610. 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?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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