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Prescription medicine

Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

Brand names: Delflex, Dianeal Low Calcium with Dextrose, Dianeal Pd-2 with Dextrose

Active ingredients: calcium chloride · dextrose monohydrate · magnesium chloride · sodium chloride · sodium lactate

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
To be discontinuedFDA shortage list
18Recalls (FDA reports)
3Companies
1978First FDA approval on file

Quick answers

What is Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose used for?
The FDA-approved label (Delflex, Fresenius Medical Care Renal Therapies Group, LLC, August 18, 2026) says: “1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis. For treatment of chronic kidney failure.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose have a boxed warning?
No. None of the 5 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose?
The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated September 10, 2026). Ask your pharmacist about alternatives.
Has Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose been recalled?
FDA enforcement reports list 18 recalls of products of this medicine; the newest started June 18, 2024 (Class II). A recall usually concerns specific lots, not every product.
Who makes Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose?
3 companies list prescription products of Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose in the FDA NDC Directory, including Vantive US Healthcare LLC, Fresenius Medical Care Renal Therapies Group, LLC and Fresenius Medical Care de Mexico, S.A. de C.V..

What Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis. For treatment of chronic kidney failure.

— FDA label: Delflex, Fresenius Medical Care Renal Therapies Group, LLC, effective August 18, 2026. Read the full label on DailyMed →

The FDA has 5 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 5 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Solution
RouteIntraperitoneal
Prescription products23 in the FDA NDC Directory
Brand namesDelflex, Dianeal Low Calcium with Dextrose, Dianeal Pd-2 with Dextrose

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA017512
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER, DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER		 Vantive Us HlthcareSeptember 27, 1978 101, latest April 16, 2026
2026: Manufacturing (CMC) · 2016: Manufacturing (CMC) · 2016: Labeling
NDA018883
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER		 Fresenius MedclNovember 30, 1984 42, latest January 26, 2021
2021: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC)
NDA020163
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER		 Vantive Us HlthcareDecember 4, 1992 18, latest June 5, 2023
2023: Labeling · 2016: Labeling · 2015: Labeling
NDA020171
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER		 Fresenius MedclAugust 19, 1992 21, latest January 26, 2021
2021: Labeling · 2016: Manufacturing (CMC) · 2015: Labeling
NDA020183
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER		 Vantive Us HlthcareDecember 4, 1992 17, latest June 5, 2023
2023: Labeling · 2016: Labeling · 2015: Labeling

Shortage status

To be discontinued · updated September 10, 2026 · first posted September 10, 2026

ProductDELFLEX, 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)
CompanyFresenius Medical Care North America

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. June 18, 2024 · Class II · Ongoing · D-0608-2024

    This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

    DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitone — Fresenius Medical Care Holdings, Inc.

  2. June 17, 2024 · Class II · Ongoing · D-0587-2024

    Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

    Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-0 — Baxter Healthcare Corporation

  3. December 28, 2023 · Class II · Ongoing · D-0218-2024

    Lack of Sterility Assurance

    DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62. — Fresenius Medical Care Holdings, Inc.

  4. August 11, 2023 · Class II · Terminated · D-1141-2023

    Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

    Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07 — Baxter Healthcare Corporation

  5. August 11, 2023 · Class II · Terminated · D-1140-2023

    Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L — Baxter Healthcare Corporation

  6. March 15, 2023 · Class II · Completed · D-0543-2023

    Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

    Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04. — Baxter Healthcare Corporation

  7. March 15, 2023 · Class II · Completed · D-0542-2023

    Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

    Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container ba — Baxter Healthcare Corporation

  8. April 28, 2021 · Class III · Terminated · D-0609-2021

    Temperature Abuse: Product exposed to temperature outside specified limits.

    DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92 — Fresenius Medical Care Holdings, Inc.

  9. April 28, 2021 · Class III · Terminated · D-0607-2021

    Temperature Abuse: Product exposed to temperature outside specified limits.

    DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92 — Fresenius Medical Care Holdings, Inc.

  10. April 28, 2021 · Class III · Terminated · D-0605-2021

    Temperature Abuse: Product exposed to temperature outside specified limits.

    DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius — Fresenius Medical Care Holdings, Inc.

  11. April 28, 2021 · Class III · Terminated · D-0610-2021

    Temperature Abuse: Product exposed to temperature outside specified limits.

    DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Walt — Fresenius Medical Care Holdings, Inc.

  12. April 28, 2021 · Class III · Terminated · D-0608-2021

    Temperature Abuse: Product exposed to temperature outside specified limits.

    DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Me — Fresenius Medical Care Holdings, Inc.

  13. April 14, 2021 · Class II · Terminated · D-0389-2021

    Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

    Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451 — Fresenius Medical Care, North America

  14. January 2, 2019 · Class II · Terminated · D-0351-2019

    Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

    Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52. — Baxter Healthcare Corporation

  15. December 20, 2017 · Class II · Terminated · D-0604-2018

    Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.

    DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451. — Fresenius Medical Care Renal Therapies Group, LLC

  16. August 7, 2014 · Class I · Terminated · D-1610-2014

    Presence of Particulate Matter: particulate matter was found during the manufacturing process.

    Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05. — Baxter Healthcare Corp.

  17. February 11, 2014 · Class I · Terminated · D-1276-2014

    Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

    Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 — Baxter Healthcare Corp.

  18. July 24, 2013 · Class II · Terminated · D-831-2013

    Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

    DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07 — Baxter Healthcare Corp.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)799999, 800003, 800057, 800061, 800062, 800064, 800066, 800074, 800111, 800115 … (+2)
SPL set ID of the quoted labelbbc5b820-4973-11e2-a192-0002a5d5c51b
FDA labels (SPL)5
FDA applicationsNDA017512, NDA018883, NDA020163, NDA020171, NDA020183
Active ingredients (FDA)CALCIUM CHLORIDE / DEXTROSE MONOHYDRATE / MAGNESIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Delflex, Fresenius Medical Care Renal Therapies Group, LLC, effective August 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers