Drug product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
D-66295-001
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 187,150 vials
- Official record key
drug-enforcement:D-66295-001
Official wording
Reason: Lack of Assurance of Sterility; potential for vial breakage
Code information: Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
Distribution pattern: Nationwide and Guam and Abu Dhabi
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility