FDA-Drug2020-08-05Class II

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.

POLARIZED LLC
Hazard

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

Sold states
Distributed in VA with potential for Nationwide distribution in USA
Affected count
18, 126 bottles
Manufactured in
16192 Coastal Hwy, N/A, Lewes, DE, United States
Products
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.

Official notice

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

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