Edge Pharma recalls sterile ophthalmic solution with potential contamination risk. Affected units may cause eye infections if used. Consumers should contact Edge Pharma for details.
Lack of Assurance of Sterility.
Edge Pharma is recalling a specific ophthalmic solution product due to a lack of assurance of sterility. This could lead to eye infections if the product is used.
The product lacks assurance of sterility, meaning it could be contaminated with bacteria or other pathogens. If used in the eye, this contamination could cause infections or other eye issues.
People who have purchased the Edge Pharma Edetate Disodium (EDTA) Sterile Ophthalmic Solution 1.5% 10 mL per dropper for eye use. Those with the specific NDC number 05446-1427-10 are most at risk.
Check for the product name 'Edetate Disodium (EDTA) Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use' from Edge Pharma. The NDC number 05446-1427-10 identifies the affected units.
Verify the product name and NDC number to confirm if it matches the recalled item.
The recall states there is a lack of assurance of sterility, so it may not be safe for eye use. Do not use the product until you confirm it's not affected.
The recall record does not specify a replacement option or remedy.
The recall record does not provide specific instructions for affected consumers beyond checking product details.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0400-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0400-2022 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.
