Prescription medicine
Calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate Brand names: Delflex
Calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate (Delflex) is a prescription medicine with an FDA approval on record since 1978. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: the calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate FDA label on DailyMed (effective July 15, 2019, Fresenius Medical Care Renal Therapies Group, LLC); the NDA 17512 record on Drugs@FDA; every calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate label on DailyMed.
Highlights of the record
FDA label of July 15, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDELFLEX ® peritoneal dialysis solutions are indicated in the treatment of chronic renal failure patients being maintained on peritoneal dialysis when nondialytic medical therapy is judged to be inadequate.
Forms and strengths
- 1.5 g/100ml / 538 mg/100ml / 448 mg/100ml / 18.4 mg/100ml / 5.08 mg/100ml
- 1.5 g/100ml / 538 mg/100ml / 448 mg/100ml / 25.7 mg/100ml / 5.08 mg/100ml
- 1.5 g/100ml / 538 mg/100ml / 448 mg/100ml / 18.3 mg/100ml / 5.08 mg/100ml
- 1.5 g/100ml / 567 mg/100ml / 392 mg/100ml / 25.7 mg/100ml / 15.2 mg/100ml
- 2.5 g/100ml / 538 mg/100ml / 448 mg/100ml / 18.3 mg/100ml / 5.08 mg/100ml
- 2.5 g/100ml / 538 mg/100ml / 448 mg/100ml / 18.4 mg/100ml / 5.08 mg/100ml
- 2.5 g/100ml / 538 mg/100ml / 448 mg/100ml / 25.7 mg/100ml / 5.08 mg/100ml
- 2.5 g/100ml / 567 mg/100ml / 392 mg/100ml / 25.7 mg/100ml / 15.2 mg/100ml
- 4.25 g/100ml / 538 mg/100ml / 448 mg/100ml / 18.4 mg/100ml / 5.08 mg/100ml
- 4.25 g/100ml / 538 mg/100ml / 448 mg/100ml / 25.7 mg/100ml / 5.08 mg/100ml
- 4.25 g/100ml / 538 mg/100ml / 448 mg/100ml / 18.3 mg/100ml / 5.08 mg/100ml
- 538 mg/100ml / 448 mg/100ml / 18.4 mg/100ml / 5.08 mg/100ml / 2.5 g/100ml
Injection (solution); solution.
On the market
- Earliest approval on file
- September 27, 1978 Dianeal Low Calcium W/Dextrose 4.25% In Plastic Container, Vantive Us Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 13, 1994; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 25 past records
- Recalls by its makers (FDA)
- 18 since 2013 2 Class I among all firms' recalls; latest June 18, 2024
- FAERS reports
- 16,942 through July 30, 2026
What is calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate used for?
From the label: indications and usageDELFLEX ® peritoneal dialysis solutions are indicated in the treatment of chronic renal failure patients being maintained on peritoneal dialysis when nondialytic medical therapy is judged to be inadequate.
FDA pharmacologic class: Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative and Phosphate Binder.
Source: FDA drug label (DELFLEX), Fresenius Medical Care Renal Therapies Group, LLC, effective July 15, 2019 (SPL set 251f0061-e7ae-11e1-aff1-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate (Delflex)?
The FDA approved the first generic calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate on June 13, 1994. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1978 earliest approval on file
- 1994 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate in shortage?
No calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 25 records are all marked to be discontinued, the latest updated September 10, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| DELFLEX, Solution, 18.4 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 46163-212-95) | Fresenius Medical Care North America | To Be Discontinued | September 10, 2026 |
| DELFLEX® w/Dextrose, Solution, 1.5% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 49230-206-94) | Fresenius Medical Care North America | To Be Discontinued | March 10, 2026 |
| DELFLEX® w/Dextrose, Solution, 1.5% Low Mg/Low Ca 2L, 5/cs (NDC 46163-206-92) | Fresenius Medical Care North America | To Be Discontinued | March 10, 2026 |
| DELFLEX® w/Dextrose, Solution, 2.5% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 49230-209-94) | Fresenius Medical Care North America | To Be Discontinued | March 10, 2026 |
| DELFLEX® w/Dextrose, Solution, 2.5% Low Mg/Low Ca 2L, 5/cs (NDC 49230-209-92) | Fresenius Medical Care North America | To Be Discontinued | March 10, 2026 |
| DELFLEX® w/Dextrose, Solution, 4.25% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 46163-212-94) | Fresenius Medical Care North America | To Be Discontinued | March 10, 2026 |
| DELFLEX® w/Dextrose, Solution, 4.25% Low Mg/Low Ca 2L, 5/cs (NDC 46163-212-92) | Fresenius Medical Care North America | To Be Discontinued | March 10, 2026 |
| DIANEAL Low Calcium with Dextrose, Intraperitoneal Injection, Solution, 18.3 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0409-07) | Vantive US Healthcare LLC | To Be Discontinued | August 3, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate been recalled?
The FDA's Enforcement Report lists 18 recalls naming calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate since 2013: 2 Class I (the most serious), 11 Class II, 5 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 18, 2024 | Class II | Fresenius Medical Care Holdings, Inc. | This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. |
| June 17, 2024 | Class II | Baxter Healthcare Corporation | Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. |
| December 28, 2023 | Class II | Fresenius Medical Care Holdings, Inc. | Lack of Sterility Assurance |
| August 11, 2023 | Class II | Baxter Healthcare Corporation | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. |
| March 15, 2023 | Class II | Baxter Healthcare Corporation | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. |
| April 28, 2021 | Class III | Fresenius Medical Care Holdings, Inc. | Temperature Abuse: Product exposed to temperature outside specified limits. |
| April 14, 2021 | Class II | Fresenius Medical Care, North America | Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. |
| January 2, 2019 | Class II | Baxter Healthcare Corporation | Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate?
The FDA Adverse Event Reporting System holds 16,942 reports that list calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,620 are coded as a death and 6,862 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other blood coagulation factors
- the pharmacologic class, with prices and generics
- Calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate side effects
- the label's list beside FAERS reports
- Calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other