Quick answers
- What is Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride used for?
- The FDA-approved label (Plegisol, Hospira, Inc., May 27, 2026) says: “Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated August 31, 2026). Ask your pharmacist about alternatives.
- Has Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride?
- 3 companies list prescription products of Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride in the FDA NDC Directory, including Hospira, Inc., Fresenius Kabi USA, LLC and Baxter Healthcare Corporation.
What Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
— FDA label: Plegisol, Hospira, Inc., effective May 27, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution |
|---|---|
| Route | Intra-arterial |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Plegisol, Cardioplegic Solution, Cardioplegic |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hospira, Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Baxter Healthcare Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018608 PLEGISOL IN PLASTIC CONTAINER | Hospira | February 26, 1982 | 28, latest December 16, 2002 2002: Labeling · 2000: Manufacturing (CMC) · 1999: Labeling |
Generic approvals (2)
- ANDA075323Baxter Hlthcare · April 21, 2000
- ANDA214623Fresenius Kabi USA · February 18, 2022
Shortage status
To be discontinued · updated August 31, 2026 · first posted August 31, 2026
| Product | Cardioplegic Solution, Injection, Solution, 17.6 mg/100 mL; 325.3 mg/100 mL; 119.3 mg/100 mL; 643 mg/100 mL (NDC 65219-258-10) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 35a174f0-f0d7-4ec7-3f81-d3d572c059cf |
|---|---|
| FDA labels (SPL) | 3 |
| FDA applications | NDA018608, 2 ANDA |
| Active ingredients (FDA) | CALCIUM CHLORIDE / MAGNESIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Plegisol, Hospira, Inc., effective May 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →