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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/Prescription Drugs

The Medicine Shoppe Pharmacy: Gentamicin Irrigation Recalled for Lack of Assurance of Sterility

Agency Publication Date: March 31, 2020
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Summary

The Medicine Shoppe Pharmacy is recalling four bottles of Gentamicin 80mg/60 mL Irrigation solution. This recall was initiated because the product lacks the necessary assurance of sterility, which means the medication may contain contaminants. Consumers who have this product should immediately stop using it and contact their healthcare provider or pharmacist for guidance. This medication was distributed exclusively in Florida.

Risk

If an irrigation solution is not sterile, it can introduce bacteria or other pathogens directly into the body during medical procedures, potentially leading to serious infections.

What You Should Do

  1. Check your medication container for 'Gentamicin 80mg/60 mL Irrigation' from The Medicine Shoppe, located at 3524 B Tamiami Trail, Port Charlotte, FL 33952.
  2. Verify the product identifies with lot number 7016542 and a discard date of 01/12/2021.
  3. Immediately stop using the affected irrigation solution and contact your healthcare provider or pharmacist for guidance.
  4. Return any unused product to the place of purchase for a refund and contact the manufacturer for further instructions.
  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 your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

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

Affected Products

Product: Gentamicin 80mg/60 mL Irrigation
Model:
Recall #: D-1072-2020
Lot Numbers:
7016542
Date Ranges: Discard after 01/12/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85234
Status: Resolved
Manufacturer: The Medicine Shoppe Pharmacy
Sold By: The Medicine Shoppe Pharmacy
Manufactured In: United States
Units Affected: 4 bottles
Distributed To: Florida

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.