Drug product
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
D-096-2013
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 63884
- Status
- Terminated
- Classification
- Class II
- Quantity
- 145,400 vials
- Official record key
drug-enforcement:D-096-2013
Official wording
Reason: Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Code information: Lot #: 11-293-DK, Exp 05/01/13
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility