Edge Pharma recalls sterile ophthalmic solution for injection due to lack of sterility assurance. This may cause infections if used improperly. Contact for return instructions.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific ophthalmic solution for injection because it may not be sterile. Using this product could lead to eye infections if it's not properly sterilized.
The solution may not be sterile, which can lead to infections in the eye. This is a risk if the product is used without proper sterilization.
Patients who have received this ophthalmic solution for eye injections are affected. Those with eye conditions requiring injections are most at risk.
Check for the product name 'Cefuroxime, Sterile O:phthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use'. Look for the NDC code 05446-1003-01 on the packaging.
Look for the NDC code 05446-1003-01 on the packaging to confirm if this product is affected.
The recall states there is a lack of assurance of sterility, so it may not be safe to use. Do not use this product.
Check for the NDC code 05446-1003-01 on the packaging. The product was sold between December 2021 and February 2022.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0398-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0398-2022 from Edge Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
