Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25

Recall Number: D-1241-2019

Firm: Akorn Inc

Classification: Class III

Status: Terminated

Report Date: 20190501

Initiation Date: 20190423

Termination Date: 20220728

Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25