Drug product
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
D-1128-2018
Product summary
- Event
- Event 80881
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33600 bags
- Official record key
drug-enforcement:D-1128-2018
Official wording
Reason: CGMP Deviations
Code information: Lot #: P380287, Exp. date 12/2019
Distribution pattern: TX and MS only
Derived failure modes
-
Manufacturing or process control
CGMP Deviations