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