Drug product
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
D-1190-2018
Product summary
- Event
- Event 80976
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5184 bags
- Official record key
drug-enforcement:D-1190-2018
Official wording
Reason: cGMP Deviation
Code information: Lot: P380063 Exp. 12/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP Deviation