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Recall Observatory FDA recall evidence

Drug product

Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49

D-1064-2019

February 06, 2019

Class II

Product summary

Firm
Ecolab Inc
Event
Event 82344
Status
Terminated
Classification
Class II
Quantity
105 units
Official record key
drug-enforcement:D-1064-2019

Official wording

Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Code information: Lot #: HS092681, Exp. SEP 2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination