June 2020 FDA Recall Drug by Transliquid Technologies, Llc
D-1408-2020 - Chemical Contamination

This Class I drug recall was voluntarily initiated by Transliquid Technologies, Llc on June 29, 2020 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1408-2020

Reason for Recall
Chemical Contamination: Presence of Undeclared Methanol
Initiated
06-29-2020
Reported
07-29-2020
Quantity
20,340 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85957
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Transliquid Technologies, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-13-2024
Product Description About Product Description
Full technical description of the product.
Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6

Batch or Lot Expiration Information

Lot# Lots: All Lots