Edge Pharma recalls PHENYLephrine 0.9% Sodium Chloride Injection (20 mg/250mL) due to lack of sterility assurance. This product may cause infections if used improperly.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific IV injection product because it lacks proper sterility assurance. This could lead to infections if the product is used without proper sterilization.
The product lacks assurance of sterility, meaning it may contain harmful bacteria or other contaminants. If the injection is used without proper sterilization, it could cause infections in patients.
Patients prescribed this injection by a healthcare provider. Those using the product without medical supervision are at risk of infection.
Look for the product name 'PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL' with NDC 05446-1667-01. It was sold between December 2021 and February 2022.
Verify the product name and NDC code to confirm if it matches the recalled items.
The recall states there is a lack of sterility assurance, so it is not safe to use without proper sterilization.
The recall record does not specify any remedy or replacement options.
The product was recalled starting December 2021 and continued through February 2022.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0418-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0418-2022 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.
