Edge Pharma recalls 1% Lidocaine HCl Sterile Buffered Solution for injection due to lack of sterility assurance. This may cause infections if used improperly.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific lidocaine injection solution because it might not be sterile. Using this product could lead to infections, especially in medical procedures.
The product lacks proper sterility assurance, meaning it could contain harmful bacteria or other contaminants. If injected into the body, this might cause infections or other complications.
Healthcare professionals and patients using this lidocaine solution for nerve blocks or infiltration procedures. Those most at risk are individuals with compromised immune systems or those undergoing sensitive medical treatments.
Check for the product name 'Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration' from Edge Pharma. The NDC code 05446-0850-10 is also listed on the packaging.
Look for the product name and NDC code 05446-0850-10 on the packaging to confirm if it's affected.
The recall states there is a lack of assurance of sterility, so it may not be safe for medical use. Do not use this product.
Check for the product name 'Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration' and NDC code 05446-0850-10 on the packaging.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance on safe disposal or alternatives.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0395-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0395-2022 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.
