Drug product
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
D-176-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64441
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,854 Units
- Official record key
drug-enforcement:D-176-2013
Official wording
Reason: Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Code information: Lot 13-121-JT* * the lot number may be followed by 01
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility