Edge Pharma recalls 6% Phenol Sterile Solution for Injection vials due to lack of assurance of sterility. This could lead to infections if used improperly. Check your vials for NDC 05446-1476-05.
Lack of Assurance of Sterility
Edge Pharma is recalling 6% phenol sterile solution injection vials because they may not be sterile. Using these vials could cause infections if they are contaminated.
The solution may not be sterile, which can lead to infections if the vial is contaminated. This is a risk during medical procedures where sterility is critical.
Healthcare professionals and patients who use this phenol solution for injections may be affected. Those with medical conditions requiring injections are at higher risk.
Check for vials labeled 'Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection' with NDC 05446-1476-05. The product was sold between October 2021 and February 2022.
Look for the NDC code 05446-1476-05 on the vial label to confirm it is part of the recall.
The recall states there is a lack of assurance of sterility, so it is not safe to use without checking the recall status.
Check the vial label for NDC 05446-1476-05 and the product name 'Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection'.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0413-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0413-2022 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.
