Antiseptic Hand Rub Recalled for Undeclared Methanol

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Cosmetics
Drugs
Skin Care Products
Reason for Announcement:
Undeclared methanol
Company Name:
Transliquid Technologies LLC
Brand Name:
Mystic Shield
Product Description:
Mystic Shield Protection Topical Solution

Company Announcement

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 memob@transliquidtechnologies.com 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.

Read the full FDA report here.
As published by HealthyExaminer.com