Vital Care Compounder recalls sterile injectable solution containing papaverine, phentolamine, and prostaglandin due to lack of sterility assurance from FDA inspection.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Vital Care Compounder is recalling a specific injectable solution for medical use because FDA found it wasn't produced with enough sterility assurance. This could lead to infections if used improperly.
FDA inspections found the product wasn't made with proper sterility controls. This means the solution could contain harmful bacteria, leading to infections if injected.
Prescription drug users who received this specific injectable solution from Vital Care Compounder. Healthcare professionals handling the product are most at risk due to potential infection.
Check for the product name 'PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial' and lot number 65425, produced on 10/13/2022.
Look for the product name and lot number 65425 on the vial label.
The FDA found the product wasn't made with enough sterility assurance, so it's not safe to use.
Check for the product name 'PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial' and lot number 65425.
The recall doesn't specify a remedy, so contact Vital Care Compounder for guidance.
We’ve drafted a message you can send Vital Care Compounder to request your refund or repair — edit it as you like.
Subject: Recall D-0044-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0044-2023 from Vital Care Compounder. 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.
