Recalls / Class II
Class IID-0007-2022
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
- Affected lot / code info
- Lot 210806-015, exp 11/4/2021
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1015 Bowles Ave, N/A, Fenton, Missouri 63026-2394
Distribution
- Quantity
- 385 bags
- Distribution pattern
- MO
Timeline
- Recall initiated
- 2021-09-22
- FDA classified
- 2021-10-08
- Posted by FDA
- 2021-10-20
- Terminated
- 2022-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.