Drug product
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
D-1240-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 71629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 314600 bags
- Official record key
drug-enforcement:D-1240-2015
Official wording
Reason: Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Code information: Lot #: 49-084-JT; 49-119-JT
Distribution pattern: United States
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility