Edge Pharma recalls lidocaine/bupivacaine ophthalmic solution due to lack of sterility assurance. This could cause infections if used improperly. Affected products include specific syringe sizes and batch numbers from 2021.
Lack of Assurance of Sterility
Edge Pharma is recalling lidocaine and bupivacaine ophthalmic solutions that may not be sterile, posing infection risks during eye procedures. This recall affects specific syringe sizes and batch numbers sold in the U.S. from late 2021.
The solution may not be sterile, which can lead to infections if used in eye procedures. This is a serious risk because the eyes are sensitive and infections can cause vision damage or other complications.
Healthcare professionals and patients using the recalled ophthalmic solution for eye injections or procedures. Those with the specific syringe sizes and batch numbers listed in the recall are most at risk.
Check for the product name 'Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF)' on the label. Look for the syringe size (8 mL) and batch numbers from 2021 (10-2021-26 or 11-2021-09).
Identify the product by checking the label for the specific syringe size (8 mL) and batch numbers from 2021 (10-2021-26 or 11-2021-09).
The recall states there is a lack of assurance of sterility, which means it may not be safe for use and could cause infections. Do not use the product until the recall is resolved.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance on disposal or alternatives.
Check the label for the product name and batch numbers from 2021 (10-2021-26 or 11-2021-09).
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0404-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0404-2022 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.
