Drug product
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
D-0334-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70174
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30840 bags
- Official record key
drug-enforcement:D-0334-2015
Official wording
Reason: Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Code information: Lot #: 42-306-C6
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility