Drug product
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
D-1514-2019
Product summary
- Event
- Event 83340
- Status
- Terminated
- Classification
- Class II
- Quantity
- 139,680 Containers
- Official record key
drug-enforcement:D-1514-2019
Official wording
Reason: Lack of Assurance of Sterility: Bags have potential to leak.
Code information: Lot #s: P389684; P389742, Exp. 8/31/2020
Distribution pattern: Nationwide in the United States and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility