Drug product
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
D-0153-2017
Product summary
- Firm
- Hospira Inc.
- Event
- Event 75619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 797,800 ampules
- Official record key
drug-enforcement:D-0153-2017
Official wording
Reason: Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Code information: Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility