Akorn recalls 2mL Sufentanil Citrate Injection due to subpotent drug levels at 30-month stability. This may affect medical use. Check NDC 17478-0050-02 for affected lots.
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Akorn is recalling a specific medical injection product because it may not contain enough active ingredient after 30 months of storage. This could lead to ineffective pain management during medical procedures.
The medication may have lower-than-stated drug concentration after 30 months of storage. This could result in less effective pain relief during procedures requiring precise dosing.
Healthcare providers using this injection for pain management under medical supervision. Patients receiving this medication through a prescription are most at risk.
Check for the product name 'Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL)' on the label. Look for NDC 17478-0050-02 and lot number 031489A with expiration 03/31/2022.
Look for NDC 17478-0050-02 and lot number 031489A with expiration 03/31/2022.
The recall is due to potential lower drug concentration after 30 months, but the product is still safe for use within its expiration date if stored properly.
Check the label for NDC 17478-0050-02 and lot number 031489A with expiration 03/31/2022.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to continue using the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0460-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0460-2022 from Akorn. 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.
