Sufenta Injection Recalled Due to Manufacturing Compliance Deviations
Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription opioid injection due to CGMP deviations and the manufacturer's inability to complete stability studies. While no illnesses or injuries have been reported, an injectable opioid represents a risk-of-harm product, and the inability to verify ongoing stability constitutes a potential safety concern. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL. The product is packaged in 1 mL, 2 mL, and 5 mL ampules for intravenous or epidural use and has been distributed nationwide in the United States and Puerto Rico.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. Akorn Inc. ceased business operations and is unable to continue stability studies that verify the product maintains its required properties over time.
Patients should consult with their healthcare provider regarding this recall and their treatment options. Do not discontinue prescribed medication without consulting a physician.
The recalled product
- Product
- Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Injectable / Opioid
- Hazard
- stability-unverified
- manufacturing-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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