Edge Pharma recalls sterile lidocaine/epinephrine injection due to lack of assurance of sterility. This could cause infections if used improperly.
Lack of Assurance of Sterility
Edge Pharma is recalling lidocaine and epinephrine injection products because they may not be sterile. Using these products could lead to infections if they are not properly sterilized.
The product may not be sterile, which means it could cause infections when injected into the body. This is a serious risk because infections can lead to complications like sepsis or other medical issues.
People who have purchased or use the specific lidocaine/epinephrine injection product from Edge Pharma. Healthcare professionals and patients using this medication for medical procedures are most at risk.
Check for the product name: Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe. The NDC code 05446-1268-01 is associated with this recall.
Look for the NDC code 05446-1268-01 on the product label to confirm if it is recalled.
The recall states there is a lack of assurance of sterility, so it is not safe to use as it could cause infections.
The recall does not specify a remedy, so you should check with Edge Pharma directly for guidance.
Check the NDC code 05446-1268-01 on the product label to confirm if it is part of this 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-0396-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0396-2022 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.
