The Recall Desk
LowFDA (Drugs)·D-0454-2017·Announced 2017-02-08

Ecolab Recalls Subpotent Chlorhexidine Gluconate Foam Solution

Ecolab is recalling 427 bottles of Endure 400 Scrub-Stat foam solution because the product was found to be subpotent.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Ecolab, Inc. is voluntarily recalling 427 bottles of Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%. The affected product is packaged in 800 mL plastic (HDPE) bottles and is available in the United States, Puerto Rico, and Canada. The specific lot number is L050261 with an expiration date of 05/18.

The recall was initiated because the product was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by its label. The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and contact Ecolab, Inc. for further instructions or a refund. The recall was initiated on December 2, 2016, and was terminated on September 6, 2017.

The recalled product

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 5510
Manufacturer
Ecolab, Inc.
Affected units
427

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # L050261
  • Exp 05/18

Distribution

Distributed in 1 state: