Edge Pharma recalls gemcitabine solution due to lack of assurance of sterility. This may cause infections. Check product details and contact for remedy.
Lack of Assurance of Sterility
Edge Pharma is recalling gemcitabine solution because it might not be sterile. This could lead to infections during medical use. Affected patients should contact their healthcare provider.
The solution may not be sterile, which can cause infections in the urinary tract. This is a serious risk for patients undergoing intravesical therapy.
Patients using this medication for intravesical treatment are affected. Those with compromised immune systems are at higher risk.
Check for the product name 'Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose' on the label. The NDC code 05446-1566-50 is also associated with this product.
Reach out to your doctor or healthcare provider for guidance on next steps.
The recall states there is a lack of assurance of sterility, so it is not safe to use.
Look for the product name and NDC code 05446-1566-50 on the label.
Contact your healthcare provider for instructions on what to do next.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0403-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0403-2022 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.
