Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

FDA recall notice · announced July 23, 2014 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

Reason for recall

Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot #: 39474DK, Expiry: 03/01/2016.
Quantity: 47,400 vials
Status: Terminated
Products in this recall event:
- Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61. (D-1433-201)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.