Recall Enforment Report D-1062-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ecolab Inc, originally initiated on 02-06-2019 for the product Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33 The product was recalled due to chemical contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.. 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-1062-201902-06-201904-03-2019Class II30 unitsMoisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.Terminated
D-1061-201902-06-201904-03-2019Class IIa) 118 units, b) 3,783 unitsAdvanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.Terminated
D-1060-201902-06-201904-03-2019Class IIa) 22 units b) 314 units c) 3511 unitsGel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.Terminated
D-1064-201902-06-201904-03-2019Class II105 unitsExpress Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.Terminated
D-1063-201902-06-201904-03-2019Class II67 unitsQuick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
47593-487Ecolab AlcoholSolutionTopicalEcolab Inc.Human Otc Drug
47593-488Advanced Gel Hand Sanitizer AlcoholSolutionTopicalEcolab Inc.Human Otc Drug
47593-489Ecolab Ethyl AlcoholSolutionTopicalEcolab Inc.Human Otc Drug
47593-491Quik-care Ethyl AlcoholSolutionTopicalEcolab Inc.Human Otc Drug
47593-502Ecolab AlcoholSolutionTopicalEcolab Inc.Human Otc Drug