Product: Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
Reason for recall: Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Recall initiated: 20200203
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated