Edge Pharma recalls sterile ophthalmic solution for potential contamination risks. This product may not be sterile, causing eye infections. Consumers should contact Edge Pharma for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific ophthalmic solution due to a lack of sterility assurance. Using this product could lead to eye infections or other complications if it's not properly sterile.
The solution may not be sterile, which can lead to infections in the eye. This is a risk for people using it for eye treatments, especially if they have existing eye issues or weakened immune systems.
People who have received this ophthalmic solution for eye treatments. Those with compromised immune systems or open wounds may be at higher risk.
Check for the product name 'Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free' with the NDC code 05446-1011-01. It was sold from November 2021 through December 2021.
Reach out to Edge Pharma at 856 Hercules Dr., Colchester, VT 05446 for specific instructions on handling the product.
The recall states there is a lack of assurance of sterility, so it may not be safe for use. Do not use the product until you get official instructions from Edge Pharma.
Look for the NDC code 05446-1011-01 on the product label. It was sold between November 2021 and December 2021.
Contact Edge Pharma directly for specific instructions on what to do with the product. The recall does not specify a disposal or return process.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0409-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0409-2022 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.
