Drug product
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
D-0490-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128,050 ADD-Vantage flexible containers
- Official record key
drug-enforcement:D-0490-2015
Official wording
Reason: Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Code information: Lot# 44-110-JT; Exp 08/16
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Sterility