Product: Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
Reason for recall: Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Recall initiated: 20200325
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated