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
Reason for recall: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated: 20230426
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated