Potassium Chloride 40 mEq in 0 recalled over sterility concerns

Recall date

September 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bow…

Recall number

D-0007-2022

FDA classification

Class II

Brand / firm

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Sold / distributed

MO

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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