US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 27, 2014 (12 years ago)

Fentanyl Citrate Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Hospira Inc.
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1433-201

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Fentanyl recalls

See all
Class II · Moderate risk Ongoing

fentaNYL Citrate

Reason Subpotent Drug

IntegraDose Compounding Services LLC NDC 71139-6030-1 D-0548-2026