Drug product
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
D-0429-2015
Product summary
- Event
- Event 70695
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196,128 containers
- Official record key
drug-enforcement:D-0429-2015
Official wording
Reason: Lack of Assurance of Sterility; increased complaints received for leaks
Code information: Product code: 2B1308; Lot#: P316497, exp date: 10/2015
Distribution pattern: Nationwide and Singapore
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility