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Recall Observatory FDA recall evidence

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

D-0007-2022

September 22, 2021

Class II

Product summary

Firm
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Event
Event 88758
Status
Terminated
Classification
Class II
Quantity
385 bags
Official record key
drug-enforcement:D-0007-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot 210806-015, exp 11/4/2021

Distribution pattern: MO

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility