Ecolab Solution
FDA Recall NDC 47593-487
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 Ecolab (NDC 47593-487). 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) 22 units b) 314 units c) 3511 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
Gel 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.
Batch or Lot Expiration Information
Lot# : a) HS091281, Exp. AUG 2020, b) HS091781, Exp. AUG 2020 and c) HS082881, HS083081, and HS090781, Exp. AUG 2020
Affected Packages Involved in this Recall
47593-487-33Product
47593-487-31Product
47593-487-41Product
47593-487-26Product
47593-487-49Product
47593-487-56Product
47593-487-55Product
47593-487-65Product
47593-487-38Product
47593-487-35Product
47593-487-11Product
47593-487-91Product
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.
