FDA recall D-0215-2019
ICU Medical Inc · Class II · drug
Product
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Reason for recall
Lack of Assurance of Sterility; bags have the potential to leak
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-08
- Report date
- 2018-11-14
- Termination date
- 2021-03-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- LAKE FOREST, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2019