Drug product
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
D-0509-2019
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 82048
- Status
- Terminated
- Classification
- Class II
- Quantity
- 475320 bags
- Official record key
drug-enforcement:D-0509-2019
Official wording
Reason: CGMP Deviations
Code information: Lot #: 91-016-JT, Exp. July 01, 2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations