September 2021 FDA Recall Drug by Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
D-0007-2022 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Ssm Health Care St. Louis Dba Ssm St. Clare Health Center on September 22, 2021 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in MO and the recall is currently terminated.
Recall Number: D-0007-2022
Lack of Assurance of Sterility
09-22-2021
10-20-2021
385 bags
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MO
12-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot 210806-015, exp 11/4/2021
