Edge Pharma recalls Mitomycin-C Sterile Ophthalmic Solution due to lack of sterility assurance. This product may cause infections if used improperly. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific type of eye drop for cancer treatment because it might not be sterile. Using this product could lead to eye infections if it's not properly cleaned.
The product lacks assurance of sterility, meaning it could contain harmful bacteria. This increases the risk of eye infections, especially for people with weakened immune systems.
People who have been prescribed this eye drop for cancer treatment. Those with compromised immune systems are at higher risk of infection.
Check for the product name 'Mitomycin-C Sterile Ophthalmic Solution, Preservative Free' with NDC 05446-1009-01. It was sold from 2021.
Reach out to Edge Pharma at 856 Hercules Dr., Colchester, VT 05446 for more information about the recall.
The recall states there is a lack of sterility assurance, so it may not be safe. Do not use this product.
Look for the product name 'Mitomycin-C Sterile Ophthalmic Solution, Preservative Free' with NDC 05446-1009-01. It was sold from 2021.
Contact Edge Pharma at 856 Hercules Dr., Colchester, VT 05446 for details on the recall.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0408-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0408-2022 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.
