Highest risk U.S. Food and Drug Administration

Shine & Clean Hand Sanitizer Gel recall: Potential presence of methanol (wood alcohol)

Recall published 6+ years ago

Potential presence of methanol (wood alcohol)

Shine & Clean Prescription & OTC drugs — recalled prescription & otc drugsShine & Clean 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: Undeclared allergen or ingredient

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

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
July 9, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Shine & Clean
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Hand Sanitizer Gel

What the company announced

Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel 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 Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Lot numbers:

  • F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/: D2028753/D202528742/D202428733/ D202028689/ D201828660/ D202428734/E200128784/E200418795/
  • F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/: D202428734/D202828689/D201828660/E201628912/E201628913/E201628911/E201528902/E201528903/
  • F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/: E201628910/E201628918/E201628914/E201628915/E201628916/E201628917/ E202328969/E202428975/
  • F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/: E202528981 /E202128947/ E201728918/E201728919/E201428876/ E201828894/ E201828920/
  • F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/: E201428876/E201128850/E201328859/E200628817/E200828826/E200928840/D202128699/D202428700.

Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors.

Maquiladora Miniara S.A. de C.V. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Distributors that have Shine and Clean Hand Sanitizer which is being recalled, should stop using and distributing product and contact their clients.

Consumers who have questions about this recall can contact Maquiladora Miniara S.A. de C.V. By +52 55 33871987 + 52 55 8394 5857 or [email protected] the hours are available from 10:00 a.m. to 1:00 p.m. and from 2:00 p.m. to 4:00 p.m. Consumers should contact their doctor or healthcare provider if they have experienced any problems related to taking or using this medicine.

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 3 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.

  • F200829088/F200829095/F200829107/D202728743/D202528742/D20242873

Package size

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

  • 1000 ml
  • 1 gallon

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

Shine & Clean — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Maquiladora Miniara, S.A. de C.V. — Consumers: Maquiladora Miniara S.A. de C.V., +52 55 33871987 — Media: Héctor Carrillo, +52 55 33871987, [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 Shine & Clean 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 F200829088/F200829095/F200829107/D202728743/D202528742/D20242873. 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?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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