Drug product
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
D-243-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 624,240 units
- Official record key
drug-enforcement:D-243-2013
Official wording
Reason: Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Code information: Lot #: 22-028-JT Exp 04/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility