Drug product
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
D-613-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 61918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136,584 units
- Official record key
drug-enforcement:D-613-2013
Official wording
Reason: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Code information: Lot #: 93-153-JT, Exp 9/12
Distribution pattern: Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility