Drug product
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
D-314-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 259,050 vials
- Official record key
drug-enforcement:D-314-2013
Official wording
Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Code information: Lot 20-564-DK Exp. 02/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility