Drug product
5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38
D-0972-2017
Product summary
- Event
- Event 77676
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54,528 bags
- Official record key
drug-enforcement:D-0972-2017
Official wording
Reason: Lack of Assurance of Sterility: Bags have the potential to leak.
Code information: Lot: P361618, Exp 09/30/18;
Distribution pattern: Nationwide, Puerto Rico and Saudi Arabia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility