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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/Topical Products

Clinical TREAT Antifungal Powder Recalled for Potency and Manufacturing Issues

Agency Publication Date: November 7, 2023
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Summary

Medline Industries, LP is recalling Clinical TREAT Antifungal Powder (miconazole nitrate 2.0%) because it was shipped to warehouses and sold while still under investigation for low levels of its active ingredient. This manufacturing issue means the product may not have the required strength to effectively treat fungal infections as labeled. No injuries or incidents have been reported, and the recall affects vanilla-scented powder sold in 3 oz tubes. Consumers who have the affected product should stop using it and seek a refund or dispose of it.

Risk

The product may contain low levels of the active ingredient miconazole nitrate, which can make the antifungal treatment less effective. This poses a risk that fungal infections may persist, worsen, or fail to clear as expected during treatment.

What You Should Do

  1. This recall affects Clinical TREAT Antifungal Powder (Vanilla Scent) sold in 3 oz (85 g) tubes with NDC 53329-169-79 and manufactured for Medline Industries, LP.
  2. Check the packaging for Lot 007782 and an expiration date of 08/31/2024 to determine if your product is included in the recall.
  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 the manufacturer 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: Clinical TREAT Antifungal Powder, Vanilla Scent (3 OZ / 85 g)
Variants: Vanilla Scent, 3 OZ (85 g) tube, Miconazole Nitrate 2.0% w/w Antifungal
Lot Numbers:
007782 (Exp 08/31/2024)
NDC:
53329-169-79

Recall #: D-0091-2024; Manufactured for Medline Industries, LP, Northfield, IL.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93227
Status: Resolved
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medline warehouse
Manufactured In: United States
Distributed To: Nationwide

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.