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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

Edge Pharma, LLC: Ceftazidime Ophthalmic Solution Recalled for Sterility Concerns

Agency Publication Date: January 19, 2021
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Summary

Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution (22.5mg/ml), an injectable medication used for intraocular treatment. The recall was initiated because the testing media used to confirm the sterility of the product after compounding was expired, meaning the company cannot guarantee the medication is free from contamination. This compounded drug was distributed nationwide to hospitals and medical offices in 0.5ml single-use syringes.

Risk

Using a medication that lacks assurance of sterility poses a risk of introducing bacteria or fungi directly into the eye during injection. This can lead to serious infections, potential vision loss, or other systemic health complications, particularly for patients with compromised immune systems.

What You Should Do

  1. Identify if you have the affected product by checking the label for Ceftazidime Sterile Ophthalmic Solution for Injection (11.25mg / 0.5ml) in 0.5ml syringes.
  2. Check the syringe or packaging for Lot # 02-2020-04@4 or Lot # 02-2020-04 to confirm it is part of the recall.
  3. Immediately stop using the affected medication and quarantine any remaining stock to prevent further use.
  4. Contact your healthcare provider or pharmacist immediately if you have received this injection and are experiencing any unusual symptoms or vision changes.
  5. Return any unused product to the place of purchase or the pharmacy where it was obtained for a refund.
  6. Contact Edge Pharma, LLC at 1-802-992-1178 for specific instructions on how to return the product and for any further questions.
  7. For additional information, 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 and contact the manufacturer for further instructions.

Affected Products

Product: Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) (0.5ml syringe)
Model:
Recall #: D-0238-2021
Lot Numbers:
02-2020-04@4
02-2020-04

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87135
Status: Resolved
Manufacturer: Edge Pharma, LLC
Sold By: Hospitals; Medical Offices
Manufactured In: United States
Units Affected: 48 syringes
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.