CLASS I Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report
Potassium Chloride Injection recalled by Baxter Healthcare
Baxter Healthcare is recalling Potassium Chloride Injection, 20 mEq per Sterile Single Dose Container, distributed nationwide in the US. The recall was initiated on 11 Jul 2014 and the FDA has classified it as Class I.
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-1593-2014
- FDA event ID
- 68728
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Potassium Chloride
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Jul 2014
- FDA classified
- 18 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Jul 2014 | Recall initiated by company | |
| 18 Sep 2014 | Classified by FDA | +69 days |
| 24 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Product as listed by the FDA
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
Where it was distributed
Nationwide, Puerto Rico, Singapore, and Hong Kong
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Which lots are affected?
Lot #: P309476, Exp 10/14
Where was it sold?
Nationwide, Puerto Rico, Singapore, and Hong Kong
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
2 other products · FDA event 68728This product is part of a recall event; the main page for the event is 0.9% Sodium Chloride Injection USP Mini-bag Plus Container recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 0.9% Sodium Chloride Injection USP Mini-bag Plus Container recalledSodium Chloride | Baxter Healthcare | Particulate Matter | Nationwide | |
| CLASS I | 0.9% Sodium Chloride Injection recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | Nationwide |
More recalls from Baxter Healthcare
All 564| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| 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 |