Edge Pharma recalls 10mL ophthalmic solution with potential lack of sterility. This could cause infection if used. Affected units sold Dec 2021.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific eye drop solution due to a lack of assurance of sterility. Using this product could lead to eye infections if the solution isn't sterile.
The solution may not be sterile, which could lead to eye infections. This is a risk for people using the product for medical purposes.
People who bought this eye drop solution from Dec 2021. Those with eye conditions or using the product for medical reasons are most at risk.
Check for the product name: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 10%/0.25%/0.25%/0.125%, 10mL. It was sold in December 2021.
Look for the product name and NDC code 05446-0859-03 on the label.
The recall states there is a lack of assurance of sterility, which could cause eye infections. Do not use the product.
The recall does not specify a remedy, so check with Edge Pharma for guidance.
The product was sold starting in December 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-0422-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0422-2022 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.
