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Recall Observatory FDA recall evidence

Drug 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.

D-1412-2020

June 25, 2020

Class II

Product summary

Firm
POLARIZED LLC
Event
Event 85944
Status
Terminated
Classification
Class II
Quantity
18, 126 bottles
Official record key
drug-enforcement:D-1412-2020

Official wording

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

Code information: Lot # all lots to include 53131626

Distribution pattern: Distributed in VA with potential for Nationwide distribution in USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    presence of undeclared methanol
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations