Unrated Drug recall · FDA · Published September 22, 2021

SSM Health Care Potassium Chloride Solution Recall: Lack of Sterility Assurance

SSM Health Care recalls Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270mL bags due to lack of sterility assurance. This affects prescription-only products with specific NDC and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0007-2022Drug SSM Health Care ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmSSM Health Care St. Louis DBA SSM St. Clare Health Center1015 Bowles Ave · Fenton, MO 63026-2394

✎ GovInfoNow plain-language explainer

SSM Health Care is recalling prescription potassium chloride solutions because they may not be sterile. This could lead to infections if used improperly. The affected products have specific lot numbers and expiration dates. Read more at govinfonow.com/recall/35845-ssm-health-care-potassium-chloride-solution-recall-lack-of-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/35845-ssm-health-care-potassium-chloride-solution-recall-lack-of-sterility · Updated August 18, 2026 · FDA enforcement record: FDA #D-0007-2022

Cite this page

“SSM Health Care Potassium Chloride Solution Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35845-ssm-health-care-potassium-chloride-solution-recall-lack-of-sterility. Based on FDA recall #D-0007-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0007-2022%22&limit=1).

The FDA announced on 2021-09-22 that SSM Health Care St. Louis DBA SSM St. Clare Health Center voluntarily recalled Potassium Chloride 40 mEq in 0.9% Sodium Chloride due to a lack of assurance of sterility. The Class II recall affects 385 bags distributed in Missouri.

How to tell if you have it

Brand: SSM Health Care
Product: Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag
NDC: 60652-6429-1
Lot: 210806-015
Expiration: 11/4/2021
Quantity: 385 bags
Distribution: MO

The hazard

The recall was issued because the firm could not assure the sterility of the product. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show SSM Health Care St. Louis DBA SSM St. Clare Health Center has 3 other recalls on record since 2017-08-10. On 2024-02-29, the company recalled IV Phenylephrine HCl Syringes due to a sterility risk. Other recent recalls of similar products include Fresenius Kabi 1000mL Sodium Chloride Injection Recall (2026-03-11), Fresenius Kabi 0.9% Sodium Chloride Injection Recall (2026-03-11), and Fresenius Kabi Recalls Sodium Chloride Injection Due to Lack of Sterility Assurance (2026-03-11).

How to tell if you have this one

Check for the product name 'Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag' with prescription-only status. Look for NDC 60652-6429-1 and lot number 210806-015.

Brand
SSM Health Care
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, NDC code 60652-6429-1, and lot number 210806-015 to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed in Missouri.

FDA distribution: “MO” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Sep 22, 2021Firm started the recall
Oct 8, 2021FDA classified it Class II
Oct 20, 2021Published in FDA’s Enforcement Report
Dec 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35845-ssm-health-care-potassium-chloride-solution-recall-lack-of-sterility">SSM Health Care Potassium Chloride Solution Recall: Lack of Sterility Assurance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0007-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0007-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.