Drug product
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38
D-0973-2017
Product summary
- Event
- Event 77676
- Status
- Terminated
- Classification
- Class II
- Quantity
- 295,200 bags
- Official record key
drug-enforcement:D-0973-2017
Official wording
Reason: Lack of Assurance of Sterility: Bags have the potential to leak.
Code information: Lots: P361501, P361667, and P361790, Exp 09/30/18
Distribution pattern: Nationwide, Puerto Rico and Saudi Arabia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility