FDA Drug Recalls

Recalls / Class II

Class IID-1064-2019

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

Brand name
Ecolab
Generic name
Alcohol
Active ingredient
Alcohol
Route
Topical
NDC
47593-502
FDA application
505G(a)(3)
Affected lot / code info
Lot #: HS092681, Exp. SEP 2020

Why it was recalled

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

Recalling firm

Firm
Ecolab Inc
Manufacturer
Ecolab Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
Level 7 370 N, N/A, Saint Paul, Minnesota 55102

Distribution

Quantity
105 units
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2019-02-06
FDA classified
2019-03-27
Posted by FDA
2019-04-03
Terminated
2022-08-11
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1064-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.