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: Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

Code information: Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.

Distribution pattern: Nationwide in the U.S. and Puerto Rico