Drug product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
D-395-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67045
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65109 vials
- Official record key
drug-enforcement:D-395-2014
Official wording
Reason: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Code information: Lot #32-484-EV, 32-485-EV Exp: 2/2015.
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility