Pharmacy Innovations recalls GENTAMICIN BLADDER irrigation products due to FDA finding insanitary conditions at manufacturing facility. Products may not be sterile, risking infection.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Pharmacy Innovations is recalling specific GENTAMICIN BLADDER irrigation products because FDA inspections found unsanitary conditions at their facility. This could mean the products aren't sterile, increasing infection risk during medical use.
FDA inspections found unsanitary conditions at Pharmacy Innovations' facility. This lack of sterility could lead to infections if the irrigation products are used improperly.
Patients using these irrigation products for medical purposes. Those with compromised immune systems or open wounds may be at higher risk.
Check for GENTAMICIN BLADDER irrigation products with 0.08mg/ml (60ml syringe), 0.48mg/ml (30ml syringe), 0.48mg/ml (60ml syringe), or 0.64mg/ml (25ml syringe) labels. These were sold in Erie, PA starting around 2022.
Look for specific GENTAMICIN BLADDER irrigation products with the listed concentrations and syringe sizes.
FDA inspections found unsanitary conditions at Pharmacy Innovations' facility, which could mean the products aren't sterile.
The recall record does not specify a remedy, so contact Pharmacy Innovations directly for guidance.
The lack of sterility could lead to infections if used improperly, but the recall record does not mention serious injury risks.
We’ve drafted a message you can send Pharmacy Innovations to request your refund or repair — edit it as you like.
Subject: Recall D-0209-2023 — Pharmacy Innovations Pharmacy Innovations Hello, I own a Pharmacy Innovations that is covered by recall D-0209-2023 from Pharmacy Innovations. 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.
