Edge Pharma recalls sterile ophthalmic solution for injection due to lack of sterility assurance. This may cause infections if used improperly. Contact for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific epinephrine/lidocaine ophthalmic solution because it lacks sterility assurance. Using this product could lead to eye infections if it's not properly sterile.
The product lacks sterility assurance, meaning it might not be clean enough to prevent infections when used in the eye. This could lead to serious eye infections if the solution is not sterile.
People who have this specific ophthalmic solution for eye injections. Those with medical conditions requiring this medication are most at risk.
Check for the product name 'Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe'. It was sold by Edge Pharma starting in 2021.
Look for the product name and NDC code 05446-0863-01 on the label.
The recall states there is a lack of sterility assurance, so it is not safe to use.
Check for the product name and NDC code 05446-0863-01 on the label.
The recall does not specify a remedy, so contact Edge Pharma 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-0402-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0402-2022 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.
