FDA Drug Recalls

Recalls / Class II

Class IID-0274-2019

Product

Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41

Brand name
Ecolab
Generic name
Benzalkonium Chloride
Active ingredient
Benzalkonium Chloride
Route
Topical
NDC
47593-521
FDA application
505G(a)(3)
Affected lot / code info
Lot# L062881, Exp 06/20, 5338HU1800, Exp 08/20

Why it was recalled

Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

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
12,540 bottles
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2018-11-09
FDA classified
2018-11-20
Posted by FDA
2018-11-28
Terminated
2020-11-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0274-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.