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Brand-name prescription medicine

DIANEAL Low Calcium with Dextrose

Generic name: Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

FDA application holder: Vantive US Hlthcare

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

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

6Strengths and forms
0Same medicine, other names
1978FDA approval
9Recalls (FDA reports)

Quick answers

What is DIANEAL Low Calcium with Dextrose?
DIANEAL Low Calcium with Dextrose is a brand name of Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose, a prescription medicine. The FDA NDC Directory lists 9 DIANEAL Low Calcium with Dextrose products in 6 strengths and forms.
Who makes DIANEAL Low Calcium with Dextrose?
Vantive US Hlthcare holds the FDA application for DIANEAL Low Calcium with Dextrose (NDA017512, approved September 27, 1978).
Is there a generic or store brand of DIANEAL Low Calcium with Dextrose?
Other products of Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose are listed with the FDA, but none in exactly the same strength and form as a DIANEAL Low Calcium with Dextrose product.
Has DIANEAL Low Calcium with Dextrose been recalled?
FDA enforcement reports list 9 recalls of DIANEAL Low Calcium with Dextrose products; the newest started June 17, 2024. A recall usually concerns specific lots, not every product.

What DIANEAL Low Calcium with Dextrose is

Each DIANEAL Low Calcium with Dextrose product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
calcium chloride 18.3 mg/100 mL · dextrose monohydrate 1.5% · magnesium chloride 5.08 mg/100 mL · sodium chloride 538 mg/100 mL · sodium lactate 448 mg/100 mL
injection, solution (intraperitoneal)		 DIANEAL Low Calcium with Dextrose None listed DailyMed
calcium chloride 18.3 mg/100 mL · dextrose monohydrate 2.5% · magnesium chloride 5.08 mg/100 mL · sodium chloride 538 mg/100 mL · sodium lactate 448 mg/100 mL
injection, solution (intraperitoneal)		 DIANEAL Low Calcium with Dextrose None listed DailyMed
calcium chloride 18.3 mg/100 mL · dextrose monohydrate 4.25% · magnesium chloride 5.08 mg/100 mL · sodium chloride 538 mg/100 mL · sodium lactate 448 mg/100 mL
injection, solution (intraperitoneal)		 DIANEAL Low Calcium with Dextrose None listed DailyMed
calcium chloride 18.4 mg/100 mL · dextrose monohydrate 1.5% · magnesium chloride 5.08 mg/100 mL · sodium chloride 538 mg/100 mL · sodium lactate 448 mg/100 mL
injection, solution (intraperitoneal)		 DIANEAL Low Calcium with Dextrose None listed DailyMed
calcium chloride 18.4 mg/100 mL · dextrose monohydrate 2.5% · magnesium chloride 5.08 mg/100 mL · sodium chloride 538 mg/100 mL · sodium lactate 448 mg/100 mL
injection, solution (intraperitoneal)		 DIANEAL Low Calcium with Dextrose None listed DailyMed
calcium chloride 18.4 mg/100 mL · dextrose monohydrate 4.25% · magnesium chloride 5.08 mg/100 mL · sodium chloride 538 mg/100 mL · sodium lactate 448 mg/100 mL
injection, solution (intraperitoneal)		 DIANEAL Low Calcium with Dextrose None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of DIANEAL Low Calcium with Dextrose products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA017512Vantive US HlthcareSeptember 27, 19786
NDA020183Vantive US HlthcareDecember 4, 19923

Companies that list DIANEAL Low Calcium with Dextrose

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of DIANEAL Low Calcium with Dextrose products.

Recalls

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, 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. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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