FDA recall D-1408-2020

Transliquid Technologies, LLC · Class I · drug

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

Reason for recall

Chemical Contamination: Presence of Undeclared Methanol

Distribution

Distributed Nationwide in the US

Key facts

Status
Terminated
Initiation date
2020-06-29
Report date
2020-07-29
Termination date
2024-03-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Spring, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1408-2020