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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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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

EnviroClean Hand Sanitizer Gel Recalled for Manufacturing Violations

Agency Publication Date: September 24, 2024
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Summary

EnviroServe Chemicals Inc. is recalling 120 bottles of EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) due to manufacturing deviations (CGMP deviations). The recall affects 16 fl. oz. (473 mL) bottles that may not have been produced under required quality control standards. Consumers should stop using the affected hand sanitizer and contact a healthcare provider if they have concerns.

Risk

Failure to follow Good Manufacturing Practices (CGMP) can result in products that are sub-standard, potentially impacting their safety, purity, or effectiveness. While no specific injuries or illnesses have been reported, use of a product with manufacturing defects poses a risk of exposure to unknown quality issues.

What You Should Do

  1. This recall affects EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) packaged in 16 fl. oz. (473 mL) bottles with NDC 76563-3010-1.
  2. Check your bottle for lot number 042224-L1 and an expiration date of 04/22/2025 printed on the packaging.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact EnviroServe Chemicals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) (16 fl. oz.)
Variants: Isopropyl alcohol 70% v/v, Gel
Lot Numbers:
042224-L1 (Exp 04/22/2025)
NDC:
76563-3010-1

Quantity: 120 bottles; Manufactured by EnviroServe Chemicals Inc. in Dunn, NC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95390
Status: Active
Manufacturer: EnviroServe Chemicals Inc.
Sold By: Distributors
Manufactured In: United States
Units Affected: 120 bottles
Distributed To: North Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.