SSM Health Care St. Louis DBA SSM St. Clare Health Center: Drug Recall

Recall #D-0007-2022 · 09/22/2021

Class II: Risk

Recall Details

Recall Number: D-0007-2022
Classification: Class II
Product Type: Drug
Recalling Firm: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Status: Terminated
Date Initiated: 09/22/2021
Location: Fenton, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 385 bags

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

Other Recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Class II: Risk 02/29/2024

Lack of Assurance of Sterility: Firm did not perform process validation.
Class II: Risk 02/29/2024

Lack of Assurance of Sterility: Firm did not perform process validation.
Class II: Risk 05/09/2023

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

View all recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.