Drug product
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
D-1168-2017
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 77956
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98,050 vials
- Official record key
drug-enforcement:D-1168-2017
Official wording
Reason: Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Code information: Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18
Distribution pattern: United States Nationwide (including Puerto Rico) and Singapore
Derived failure modes
-
Sterility assurance
Lack of sterility