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Class III: unlikely to cause harmTerminated

Ecolab Endure 400 Scrub-Stat Recall

Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in…

Ecolab, Inc. · Huntington, IN

Risk level
Class III
Reported by FDA
Feb 8, 2017
Recall ID
D-0454-2017
Check your lot numberHow we source this data

Summary

Ecolab recalled Endure 400 Scrub-Stat starting Dec 2, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0454-2017 on Feb 8, 2017. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

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

Lot numbers, UPCs & expiration codes

Lot # L050261, Exp 05/18

Where it was sold

United States, Puerto Rico and Canada

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0454-2017
Classification
Class III
Status
Terminated
Recall initiated
Dec 2, 2016
FDA report date
Feb 8, 2017
Quantity
427 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ecolab, Inc.

Original FDA data

Every field from FDA enforcement report D-0454-2017, exactly as published.

Show all FDA fields
City
Huntington
State
IN
Status
Terminated
Country
United States
Event ID
76177
Address
970 E Tipton St
Code information
Lot # L050261, Exp 05/18
Postal code
46750-1611
Report date
Feb 8, 2017
Product type
Drugs
Recall number
D-0454-2017
Classification
Class III
Recalling firm
Ecolab, Inc.
Product quantity
427 bottles
Termination date
Sep 6, 2017
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
United States, Puerto Rico and Canada
Recall initiation date
Dec 2, 2016
Initial firm notification
Letter
Center classification date
Jan 31, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0454-2017, published Feb 8, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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