FDA Drug Recalls

Recalls / Class III

Class IIID-1393-2019

Product

QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82

Brand name
Quik-care
Generic name
Ethyl Alcohol
Active ingredient
Alcohol
Route
Topical
NDC
47593-490
FDA application
505G(a)(3)
Affected lot / code info
Lot #: C040591, Exp 4/21

Why it was recalled

Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

Recalling firm

Firm
Ecolab Inc
Manufacturer
Ecolab Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Ecolab Pl, N/A, Saint Paul, Minnesota 55102-2739

Distribution

Quantity
183 cases
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2019-05-10
FDA classified
2019-06-18
Posted by FDA
2019-06-26
Terminated
2022-09-17
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1393-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.