Drug product
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
D-608-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65400
- Status
- Terminated
- Classification
- Class II
- Quantity
- 676,872 containers
- Official record key
drug-enforcement:D-608-2013
Official wording
Reason: Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Code information: Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility