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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Ecolab, Inc.: Endure 400 Scrub-Stat Chlorhexidine Gluconate Recalled for Low Potency

Agency Publication Date: August 21, 2018
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Summary

Ecolab, Inc. is recalling 427 bottles of Endure 400 Scrub-Stat (chlorhexidine gluconate) 4% Foam Forming Solution because the product is subpotent, meaning it may not contain the required strength of its active ingredient. This recall affects one specific lot of the over-the-counter antimicrobial skin cleanser distributed in 800 mL plastic bottles across the United States, Puerto Rico, and Canada. If you are using this product, contact your healthcare provider or pharmacist for guidance regarding its effectiveness and return any unused portions to the place of purchase.

Risk

A subpotent drug may fail to provide the intended level of antimicrobial protection, potentially increasing the risk of infection when used as a surgical scrub or hand wash.

What You Should Do

  1. Check your product packaging for 'Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%' in 800 mL bottles.
  2. Locate the lot number and expiration date on the bottle: this recall specifically affects Lot # L050261 with an expiration date of 05/18 (May 2018).
  3. Confirm the Model Number and NDC: for U.S. products, look for Model Number 61430436 and NDC 47593-265-36; for Canadian products, look for Model Number 6000179.
  4. Contact your healthcare provider or pharmacist for guidance if you have been using this subpotent product.
  5. Return any unused product to the pharmacy or place of purchase for a refund.
  6. Contact Ecolab, Inc. at their Huntington, Indiana facility (970 E Tipton St) for further instructions regarding this voluntary recall.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4% (800 mL) - United States
Model:
61430436
NDC 47593-265-36
Lot Numbers:
L050261 (Exp 05/18)
Date Ranges: May 2018
Product: Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4% (800 mL) - Canada
Model:
6000179
NDC 47593-265-36
Lot Numbers:
L050261 (Exp 05/18)
Date Ranges: May 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76177
Status: Resolved
Manufacturer: Ecolab, Inc.
Sold By: Over-the-counter retailers
Manufactured In: United States
Units Affected: 427 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.