Edge Pharma recalls Mitomycin-C syringes due to lack of sterility assurance. This could lead to infections if used improperly. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
Edge Pharma is recalling certain Mitomycin-C syringes because they may not be sterile. Using these syringes could cause infections during medical procedures.
The syringes lack assurance of sterility, meaning they might contain contaminants that could cause infections when used for medical procedures. This is a risk during intravesical treatments where the medication is delivered directly into the bladder.
Patients using Mitomycin-C for intravesical treatment may be affected. Those with specific medical conditions requiring this medication are at higher risk.
Check for the product name 'Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use' and the manufacturer Edge Pharma, LLC. The recall covers specific batch numbers and dates listed in the record.
Reach out to Edge Pharma, LLC at 856 Hercules Dr., Colchester, VT 05446 for details on the recall and next steps.
The recall is due to a lack of assurance of sterility, which could lead to infections if the syringes are used improperly.
Check for the product name and batch numbers listed in the recall notice, which include specific dates and quantities.
Contact Edge Pharma, LLC directly for instructions on what to do with the product.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0407-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0407-2022 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.
