Key Takeaway

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 by POLARIZED LLC was recalled on June 25, 2020. The hazard: CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.

FDA Drug 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

Recalled: June 25, 2020 ~18, 126 bottles units affected D-1412-2020

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.

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

POLARIZED LLC

Lewes, DE, United States

View all 1 recalls by POLARIZED LLC →

Distribution

Distributed in VA with potential for Nationwide distribution in USA

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.