Akorn recalls all Sufenta 50 mcg/mL injections (1mL, 2mL, 5mL ampules) due to inability to conduct stability studies after the company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Sufenta 50 mcg/mL injections (1mL, 2mL, and 5mL ampules) because the manufacturer went out of business and can no longer perform stability testing. This means the product's safety and effectiveness cannot be guaranteed.
The recall occurs because Akorn went out of business and can no longer conduct stability studies to ensure the product remains safe and effective over time. Without this testing, the medication's quality and performance cannot be verified.
Healthcare providers and patients who have been prescribed Sufenta for intravenous or epidural use. Those most at risk are patients receiving the medication through medical facilities that use the recalled product.
Check for Sufenta 50 mcg/mL injections in 1mL, 2mL, or 5mL ampules. All products were manufactured by Akorn Inc. in Lake Forest, IL and have all National Drug Codes (NDCs).
Verify the product is Sufenta 50 mcg/mL injection in 1mL, 2mL, or 5mL ampules.
The manufacturer went out of business and can no longer conduct stability studies to ensure the product remains safe and effective.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
The recall is due to the inability to verify product stability, not an immediate safety hazard. No injuries have been reported.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0847-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0847-2023 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.
