Safety Report: Mystic Shield Protection Topische Lösung - zurückgerufen durch nicht deklariertes Methanol, USA

United States

Company name: Transliquid Technologies LLC
Brand name: Mystic Shield
Product recalled: Mystic Shield Protection Topical Solution
Reason of the recall: Undeclared methanol
FDA Recall date: July 02, 2020
Recall details: 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 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/transliquid-technologies-llc-issues-voluntary-recall-mystic-shield-protection-topical-solution-due

Source: FDA