Drug product
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
D-169-2013
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 64083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63,900 vials
- Official record key
drug-enforcement:D-169-2013
Official wording
Reason: Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Code information: 18-099-DK
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility