FDA recall D-0007-2022

SSM Health Care St. Louis DBA SSM St. Clare Health Center · Class II · drug

Product

Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1

Reason for recall

Lack of Assurance of Sterility

Distribution

MO

Key facts

Status
Terminated
Initiation date
2021-09-22
Report date
2021-10-20
Termination date
2022-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fenton, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2022