FDA recall D-1412-2020

Product

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.

Reason for recall

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

Distribution

Distributed in VA with potential for Nationwide distribution in USA

Key facts

Status

Terminated

Initiation date

2020-06-25

Report date

2020-08-05

Termination date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lewes, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1412-2020