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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

Medline Industries Inc: PVP Scrub Solution Recalled for Low Iodine Levels

Agency Publication Date: February 26, 2018
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Summary

Medline Industries Inc. is recalling approximately 67,104 bottles of PVP Scrub Solution, Povidone Iodine, 7.5%. This recall was initiated because the product may not maintain the required iodine levels through its labeled expiration date, making it subpotent. While no specific injuries or incidents have been reported, using a surgical scrub with insufficient active ingredients may reduce its effectiveness during use. This product was distributed nationwide across the United States and in Curacao.

Risk

The iodine level in the scrub is below the required standards, which means the solution may not effectively kill bacteria or germs as intended. This subpotency could increase the risk of infection if used for skin preparation or surgical scrubbing.

What You Should Do

  1. Check your supply for 4 FL OZ bottles of PVP Scrub Solution, Povidone Iodine, 7.5% with the following identifiers: Product Number MDS093945, NDC 53329-938-04, and Lot Number 16EJ0023.
  2. Verify if your product has an expiration date of 04/18 (April 2018).
  3. Contact your healthcare provider or pharmacist for guidance if you have recently used this product for wound care or surgical preparation.
  4. Return any unused bottles to the place of purchase for a refund or contact Medline Industries Inc. for further instructions regarding the disposal or return of the affected lot.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: PVP Scrub Solution, Povidone Iodine, 7.5% (4 FL OZ bottle)
Model:
MDS093945
NDC 53329-938-04
Lot Numbers:
16EJ0023 (Exp 04/18)
Date Ranges: Expiration Date 04/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79267
Status: Resolved
Manufacturer: Medline Industries Inc
Sold By: Medline Industries Inc
Manufactured In: United States
Units Affected: 67,104 bottles
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 · 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.