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.

Recall Number: D-0460-2022

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220119

Initiation Date: 20220105

Termination Date: 20220917

Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.

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.