Edge Pharma recalls sterile ophthalmic solution for injection due to lack of assurance of sterility. This may cause infections if used improperly.
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 if used in the eye. This is a risk for medical procedures where the solution is injected into the eye.
People who have purchased this ophthalmic solution for eye injections. Those with medical conditions requiring injections are most at risk.
Check for the product name: Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe. It was sold starting December 29, 2021, by Edge Pharma.
Look for the product name and NDC number 05446-1118-01 on the packaging.
The recall states there is a lack of assurance of sterility, so it may not be safe for eye injections.
The recall does not specify a remedy, so check with your healthcare provider for guidance.
This product was recalled starting December 29, 2021.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0419-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0419-2022 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.
