IntegraDose recalls fentanyl citrate injection vials with leaking bags due to lack of sterility. Affected lots from 20231020FEN-1 expire April 2024. Stop using immediately to prevent infection.
Lack of Assurance of Sterility: leaking bags
IntegraDose is recalling fentanyl citrate injection vials that may leak, risking infection. This is serious because medical-grade sterile products are critical for safe use and leaks could introduce contaminants.
The vials have leaking bags that can compromise sterility. This means contaminants could enter the injection, causing infections in patients during medical procedures.
Healthcare professionals using the recalled fentanyl injections for pain management. Patients receiving these injections are at risk of infection if the product leaks.
Check for the lot number 20231020FEN-1 on the vial label. The product expires April 2024. The manufacturer is IntegraDose Compounding Services LLC in Minneapolis, MN.
Discard the vial if it leaks or shows signs of contamination.
No, the recalled vials may leak and risk infection. Do not use.
Check for lot number 20231020FEN-1 on the vial label. The product expires April 2024.
Discard the vial immediately to prevent infection risk.
We’ve drafted a message you can send IntegraDose to request your refund or repair — edit it as you like.
Subject: Recall D-0432-2024 — IntegraDose IntegraDose Hello, I own a IntegraDose that is covered by recall D-0432-2024 from IntegraDose. 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.
