Drug product
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
D-1096-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 603,768 bags
- Official record key
drug-enforcement:D-1096-2014
Official wording
Reason: Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Code information: Lot 34-609-FW; Exp 10/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility