Edge Pharma recalls sterile vancomycin ophthalmic solution due to lack of sterility assurance. This may cause infections if used improperly.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific vancomycin ophthalmic solution product because it lacks sterility assurance. Using this product could lead to eye infections if it's not properly sterile.
The solution may not be sterile, which can lead to infections in the eye. This is a risk when used for intraocular injections, as the eye is sensitive to contamination.
Patients who have been prescribed this vancomycin ophthalmic solution for eye injections. Those with compromised immune systems are at higher risk of infection.
Check for the product name 'Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL)' on the label. The NDC code 05446-0736-01 is associated with this recall.
Look for the product name and NDC code 05446-0736-01 on the label.
The recall states there is a lack of sterility assurance, so it is not safe for use. Patients should not use this product.
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe alternatives.
The recall was issued on 12/12/2021 and 01/02/2022 as indicated in the NDC codes.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0424-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0424-2022 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.
