Drug product
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
D-617-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 61918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98,084 units
- Official record key
drug-enforcement:D-617-2013
Official wording
Reason: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Code information: Lots #: 04-151-JT, 06-040-JT, Exp 4/13
Distribution pattern: Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility