Advanced Gel Hand Sanitizer Solution
FDA Recall NDC 47593-488
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Advanced Gel Hand Sanitizer (NDC 47593-488). A significant event, classified as Class II, was initiated on Feb 06, 2019 by Ecolab Inc.. The reported reason for this action was: "Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Feb 06, 2019
Apr 03, 2019
a) 118 units, b) 3,783 units
Recall Profile & Regulatory Data
Event ID
82344
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ecolab Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 11, 2022
Product Description
Advanced 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.
Batch or Lot Expiration Information
Lot# : a) HS092781, Exp. SEP 2020; b) HS091381, HS091781, and HS091881, Exp. SEP 2020
Affected Packages Involved in this Recall
47593-488-33Product
47593-488-31Product
47593-488-32Product
47593-488-26Product
47593-488-56Product
47593-488-41Product
47593-488-49Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
