PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 5, 2020 Initiated: June 25, 2020 #D-1412-2020

Product Description

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.

Details

Recalling Firm
POLARIZED LLC
Units Affected
18, 126 bottles
Distribution
Distributed in VA with potential for Nationwide distribution in USA
Location
Lewes, DE

Frequently Asked Questions

What product 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.. Recalled by POLARIZED LLC. Units affected: 18, 126 bottles.
Why was this product recalled?
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 5, 2020. Severity: Moderate. Recall number: D-1412-2020.