Highest risk U.S. Food and Drug Administration

Born Basic, Scent Theory and more Hand Sanitizer recall: Undeclared methanol

Recall published 6+ years ago

Undeclared methanol

Born Basic, Scent Theory and more Prescription & OTC drugs — recalled prescription & otc drugsBorn Basic, Scent Theory and more Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Born Basic, Scent Theory and more Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Born Basic, Scent Theory and 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 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
July 23, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Born Basic, Scent Theory and more
Product type
Prescription & OTC drugs

Products covered by this recall

Hand Sanitizer

What the company announced

La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:

Born Basic ANTI-BAC HAND SANITIZER,

Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer,

Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer, and

Lux Eoi Hand Sanitizing Gel to the consumer level.

The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could 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 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, Real Clean Distribuciones SA de CV has not received reports of adverse events related to this recall.

RECALLED PRODUCTS

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. Real Clean Distribuciones SA de CV manufacturers product for four brands included in this recall.

Scent Theory and Born Basic hand sanitizer products are produced by several different manufacturers, in several different countries, and only those lots manufactured by Real Clean in Mexico are subject to the recall.

The recalled products include the following lots:

  • Manufacturer: Real Clean Distribuciones S.A. De C.V. · Product: Scent Theory Keep Clean Hand Sanitizer 70% Alcohol · Country of Origin: Mexico · Size: 16.9oz · Lot Numbers: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220
  • Manufacturer: Real Clean Distribuciones S.A. De C.V. · Product: Keep it Clean Hand Sanitizer 70% Alcohol · Country of Origin: Mexico · Size: 16.9oz · Lot Numbers: 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220
  • Manufacturer: Real Clean Distribuciones S.A. De C.V. · Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol · Country of Origin: Mexico · Size: 16.9oz · Lot Numbers: 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420
  • Manufacturer: Real Clean Distribuciones S.A. De C.V. · Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol · Country of Origin: Mexico · Size: 34oz · Lot Numbers: 0133420, 0233420, 0333420, 0433420, 0533420, 0633420
  • Manufacturer: Real Clean Distribuciones S.A. De C.V. · Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol · Country of Origin: Mexico · Size: 9.5oz · Lot Numbers: 0133720, 0233720
  • Manufacturer: Real Clean Distribuciones S.A. De C.V. · Product: Lux Eoi Hand Sanitizing Gel · Country of Origin: Mexico · Size: 16.9oz · Lot Numbers: 0133920, 0233920, 0333920

Real Clean Distribuciones SA de CV is notifying its distributors by recall letter and consumers via this press release. Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase; because the affected products are considered hazardous materials, do not destroy the affected products.

Consumers with questions regarding this recall can contact Stericycle during the following hours: Sunday - Saturday 08:00 am - 8:00 pm EST at:

Toll Free: 866-512-4073

FAX: 844-294-7183

Email: [email protected]

Event: 4107

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 23 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.

  • 1633220
  • 1733220
  • 1833220
  • 1933220
  • 2033220
  • 2133220
  • 2233220
  • 2333220
  • 0133220
  • 0233220
  • 0333220
  • 0433220
  • 0533220
  • 0633220
  • 0733220
  • 0833220
  • 0833420
  • 0933420
  • 1033420
  • 1133420

Package size

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

  • 16.9 oz
  • 34 oz
  • 9.5 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

Born Basic, Scent Theory and 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.

Remedy named in the notice: Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

Company contact: Real Clean Distribuciones SA de CV — Consumers: Stericycle, 866-512-4073, [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 Born Basic, Scent Theory and more prescription & otc drugs recalled?

Undeclared methanol Risk Statement: Substantial methanol exposure could 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 1633220, 1733220, 1833220. 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: Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

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