Product: Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Reason for recall: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Recall initiated: 20220105
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated