FDA recall D-0509-2019
ICU Medical Inc · Class II · 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
Reason for recall
CGMP Deviations
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2019-02-04
- Report date
- 2019-02-27
- Termination date
- 2020-06-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- LAKE FOREST, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2019