Drug product
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
D-183-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 325,056 bags
- Official record key
drug-enforcement:D-183-2013
Official wording
Reason: Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Code information: Lot Number 02-117-JT Exp. 02/13
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility