Saniderm ADVANCED HAND SANITIZER recalled over undeclared methanol

Recall date

June 25, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

POLARIZED LLC recalls Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskb…

Recall number

D-1412-2020

FDA classification

Class II

Brand / firm

POLARIZED LLC

Sold / distributed

Distributed in VA with potential for Nationwide distribution in USA

Why it was recalled

CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.