Medications & Supplements/Prescription Drugs

SSM Health Care St. Louis DBA SSM St. Clare Health Center: Potassium Chloride Solution Recalled for Lack of Sterility Assurance

Agency Publication Date: October 8, 2021

Summary

SSM Health Care Corporation is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride (270 mL). This prescription drug is being recalled because the manufacturer cannot guarantee the sterility of the product, which is intended for intravenous administration. Use of a non-sterile injectable medication can lead to serious, life-threatening infections.

Risk

A lack of sterility assurance means the medication could be contaminated with bacteria or other microorganisms. When such contaminants are injected directly into the bloodstream, they can cause systemic infections or sepsis, which may be fatal.

What You Should Do

Check your medical supplies for Potassium Chloride 40 mEq in 0.9% Sodium Chloride, 270 mL bags with the NDC number 60652-6429-1.
Specifically look for bags labeled with Lot number 210806-015 and an expiration date of 11/4/2021.
If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance and to arrange for an alternative treatment.
Return any unused bags from the affected lot to the place of purchase or pharmacy for a refund.
Contact SSM St. Clare Health Center at their Fenton, MO location or through your provider for further instructions regarding the return of these bags.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Potassium Chloride 40 mEq in 0.9% Sodium Chloride (270 mL NS, 250 mL bag)

Model:

NDC 60652-6429-1

Lot Numbers:

210806-015 (Exp 11/4/2021)

Date Ranges: Exp 11/4/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88758

Status: Resolved

Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center

Sold By: SSM Health Care Corporation; SSM St. Clare Health Center

Manufactured In: United States

Units Affected: 385 bags

Distributed To: Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for Potassium Chloride 40 mEq in 0.9% Sodium Chloride, 270 mL bags with the NDC number 60652-6429-1.

Specifically look for bags labeled with Lot number 210806-015 and an expiration date of 11/4/2021.

If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance and to arrange for an alternative treatment.

Return any unused bags from the affected lot to the place of purchase or pharmacy for a refund.

Contact SSM St. Clare Health Center at their Fenton, MO location or through your provider for further instructions regarding the return of these bags.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.