Potassium Chloride Sodium Chloride (SSM Health) – Sterility Concern (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Lot Codes / Batch Numbers
Lot 210806-015, exp 11/4/2021
Products Sold
Lot 210806-015, exp 11/4/2021
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Co due to Lack of Assurance of Sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO
Page updated: Jan 7, 2026