Edge Pharma recalls sterile ophthalmic solution (3% EDTA) due to lack of sterility assurance. Affected products were sold from January 2022. Consumers should contact the company for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a sterile eye drop solution because it may not be sterile. Using unsterile eye drops could lead to infections or other eye problems.
The eye drop solution may not be sterile, which could cause infections or other eye issues if used. This is a risk for people who use the drops for eye care.
People who bought the specific eye drop solution from Edge Pharma in 2022 are affected. Those with sensitive eyes or recent eye injuries are at slightly higher risk.
Check for the product name 'Edetate Disodium (EDTA), Sterile Ophthalmic Solution (3%)', 10mL per dropper, and the NDC number 05446-1428-10. The product was sold starting in January 2022.
Look for the NDC number 05446-1428-10 on the product label to confirm it's affected.
The recall states there is a lack of assurance of sterility, so it may not be safe. Do not use the product until you confirm it's not affected.
The recall record does not mention a replacement option. Contact Edge Pharma directly for details.
The product was sold starting in January 2022.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0401-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0401-2022 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.
