FDA Drug Recalls

Recalls / Class II

Class IID-1063-2019

Product

Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85

Brand name
Quik-care
Generic name
Ethyl Alcohol
Active ingredient
Alcohol
Route
Topical
NDC
47593-491
FDA application
505G(a)(3)
Affected lot / code info
Lot #: HS103181, Exp. OCT 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
67 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-1063-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.