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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-1407-2020

June 22, 2020

Class I

Product summary

Firm
UVT INC
Event
Event 85942
Status
Terminated
Classification
Class I
Quantity
38,016 bottles
Official record key
drug-enforcement:D-1407-2020

Official wording

Reason: Chemical Contamination: Product contains undeclared methanol.

Code information: Lot 0530, Exp. Date 04/22

Distribution pattern: Distributed to two wholesalers in FL who may have further distributed Nationwide in the USA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination