Potassium Chloride Injection Recall Due to Sterility Assurance Lack
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Potassium chloride injection without assured sterility poses a significant risk of serious infection or harm if administered to patients, meeting the severity criterion for FDA Class II recalls with risk of serious health consequences.
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL bags (NDC 60652-6429-1) due to lack of assurance of sterility. The recall affects 385 bags from Lot 210806-015 with an expiration date of November 4, 2021.
The affected product was distributed in Missouri. Healthcare providers and patients who have received this medication should consult their healthcare provider regarding potential exposure and any necessary follow-up care. Unused product should be removed from inventory and not dispensed.
Patients with questions about this recall should contact their healthcare provider or SSM Health Care St. Louis.
The recalled product
- 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
- Manufacturer
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Hazard
- sterility-assurance
- contamination-risk
- injection-infection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 210806-015
- exp 11/4/2021
Distribution
Distributed in 1 state:
- MO
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