CLASS II Drug recall · Reported 3 Dec 2014 · FDA Enforcement Report
Potassium Chloride Injection recalled by Baxter Healthcare
Baxter Healthcare is recalling Potassium Chloride Injection, 10mEq per Sterile single dose container, distributed nationwide in the US. The recall was initiated on 10 Nov 2014 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-0256-2015
- FDA event ID
- 69518
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Potassium Chloride
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2014
- FDA classified
- 21 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Nov 2014 | Recall initiated by company | |
| 21 Nov 2014 | Classified by FDA | +11 days |
| 3 Dec 2014 | 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
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Product as listed by the FDA
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Which lots are affected?
Lot #: P319160, Exp 06/30/15
Where was it sold?
Nationwide
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.
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|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
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| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Potassium Chloride recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride | ICU Medical | Labeling Errors | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride | ICU Medical | Other | Nationwide |
| Drug | CLASS II | Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride | The Harvard Drug Group | Potency & Assay | Nationwide |