CLASS II Drug recall · Reported 20 Oct 2021 · FDA Enforcement Report
Potassium Chloride 40 mEq in 0.9% Sodium Chloride NS recalled
SSM Health Care St. Louis is recalling Potassium Chloride 40 mEq in 0.9% Sodium Chloride NS, distributed in Missouri. The recall was initiated on 22 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0007-2022
- FDA event ID
- 88758
- Recalling firm
- SSM Health Care St. Louis, Fenton, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2021
- FDA classified
- 8 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Sep 2021 | Recall initiated by company | |
| 8 Oct 2021 | Classified by FDA | +16 days |
| 20 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
MO
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot 210806-015, exp 11/4/2021
Where was it sold?
MO
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.