Recall Enforment Report D-0275-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ecolab Inc, originally initiated on 11-09-2018 for the product Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59 The product was recalled due to labeling: label mix-up - the label on the product may not match the formula in the bottle.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0275-201911-09-201811-28-2018Class II14,108 bottlesMedi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59Labeling: Label mix-up - the label on the product may not match the formula in the bottle.Terminated
D-0274-201911-09-201811-28-2018Class II12,540 bottlesEqui-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 47593-521-41Labeling: Label mix-up - the label on the product may not match the formula in the bottle.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
47593-503Ecolab Inc. ChloroxylenolLiquidTopicalEcolab Inc.Human Otc Drug
47593-521Ecolab Benzalkonium ChlorideSolutionTopicalEcolab Inc.Human Otc Drug