SterRx recalls Fentanyl Citrate injection due to lack of assurance of sterility. This could lead to infections if used improperly. Affected products include specific NDC numbers sold in New York.
Lack of Assurance of Sterility
SterRx is recalling a specific fentanyl injection product because it may not be sterile. Using this product could cause infections, especially in medical settings where sterility is critical.
The injection may not be sterile, which can lead to infections if used in medical procedures. This is particularly dangerous for patients receiving fentanyl treatments, as infections could cause serious health complications.
Healthcare professionals and patients prescribed this fentanyl injection are affected. Those using the product without proper sterility checks are at higher risk.
Check for the product name 'Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL (10 mcg per mL)' on the label. The NDC number 70324-327-01 is associated with this recall. Products were sold in Plattsburgh, NY starting in March 2022.
Look for the product name and NDC number 70324-327-01 on the injection label.
The recall states there is a lack of assurance of sterility, so it is not safe to use without proper testing.
Check the product label for the specific NDC number 70324-327-01 and the product name described in the recall.
The recall does not specify a remedy, so contact SterRx directly for guidance.
We’ve drafted a message you can send SterRx to request your refund or repair — edit it as you like.
Subject: Recall D-0316-2022 — SterRx SterRx Hello, I own a SterRx that is covered by recall D-0316-2022 from SterRx. 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.
