Highest risk U.S. Food and Drug Administration

Mystic Shield Protection Topical Solution recall: Undeclared methanol

Recall published 6+ years ago

Undeclared methanol

Mystic Shield Prescription & OTC drugs — recalled prescription & otc drugsMystic Shield 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 “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 2, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Mystic Shield
Product type
Prescription & OTC drugs
Distribution
California, Louisiana, Massachusetts, Texas

Products covered by this recall

Mystic Shield Protection Topical Solution

What the company announced

Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level. The firm’s independent testing found the products contain 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. 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, Transliquid Technologies LLC has not received any reports of adverse events related to the product in question.

The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in an 8.45 ounce (250 ml) blue or green labeled bottle with a white or transparent cap and bears a green or blue label identifying Mystic Shield Protection. The product was distributed between May 21, 2020-June 30, 2020 to select wholesale and retail customers in California, Louisiana, Massachusetts, and Texas. Transliquid Technologies LLC has accounted for and prevented distribution of a substantial majority of the product at the consumer level and is arranging for its return.

Transliquid Technologies LLC is notifying its distributors and customers by email and first-class U.S. Mail and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have Mystic Shield Protection hand sanitizer, which is being recalled, should stop using and return to the place of purchase.

Consumers with questions regarding this recall can contact Transliquid Technologies LLC at 281-377-5845 [email protected] on Monday-Friday, 8:00 am-5:00 pm CST. 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.

CDER’s Announcement

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 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

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

  • 8.45 ounce
  • 250 ml

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

Mystic Shield — 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 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.

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: Transliquid Technologies LLC — Consumers: Transliquid Technologies LLC, 281-377-5845, [email protected] — Media: Guillermo Berriochoa, 281-377-5845, [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 Mystic Shield 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?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

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.

Which states were affected?

The notice lists California, Louisiana, Massachusetts, Texas.

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