Recall: D-1433-201

Class II - Potentially Harmful

Class IIClassification

2014-06-27Initiated

TerminatedStatus

Hospira Inc.Firm

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

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

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.