December 2016 FDA Recall Drug by Ecolab, Inc.
D-0454-2017 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Ecolab, Inc. on December 2, 2016 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in United States, Puerto Rico and Canada and the recall is currently terminated.

Recall Number: D-0454-2017

Reason for Recall
Subpotent Drug
Initiated
12-02-2016
Reported
02-08-2017
Quantity
427 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76177
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ecolab, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States, Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-06-2017
Product Description About Product Description
Full technical description of the product.
Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36

Batch or Lot Expiration Information

Lot# L050261, Exp 05/18