Pharmacy Innovations recalls MITOMYCIN 0.4MG/ML OPH solutions due to FDA finding insanitary conditions at manufacturing facility. Products may not be sterile, posing infection risk.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Pharmacy Innovations is recalling three types of MITOMYCIN 0.4MG/ML OPH solutions because FDA inspections found unsanitary conditions at their facility. This could mean the products are not sterile and might cause infections if used.
FDA inspections found unsanitary conditions at Pharmacy Innovations' facility. This lack of sterility could mean the medication is contaminated and may cause infections when used.
Patients prescribed these medications by doctors are affected. Those using the products without medical supervision are at risk of infection.
Check for the product names: MITOMYCIN 0.4MG/ML (1ML DROPTAINER), (1ML VIAL), or (4ML VIAL) OPH SOLUTION. These were sold by Pharmacy Innovations in Erie, PA starting around October 2022.
Identify the product by checking the label for MITOMYCIN 0.4MG/ML OPH SOLUTION in 1ML, 4ML, or droptainer form.
FDA inspections found unsanitary conditions at Pharmacy Innovations' facility, which could mean the medication is not sterile.
The recall record does not specify a remedy, so contact Pharmacy Innovations directly for guidance.
The recall indicates potential contamination risk, so it is not safe to use without confirming it's not recalled.
We’ve drafted a message you can send Pharmacy Innovations to request your refund or repair — edit it as you like.
Subject: Recall D-0224-2023 — Pharmacy Innovations Pharmacy Innovations Hello, I own a Pharmacy Innovations that is covered by recall D-0224-2023 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.
