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Brand-name prescription medicine

Delflex

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

FDA application holder: Fresenius Medcl

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

5Strengths and forms
0Same medicine, other names
1984FDA approval
9Recalls (FDA reports)

Quick answers

What is Delflex?
Delflex is a brand name of Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose, a prescription medicine. The FDA NDC Directory lists 8 Delflex products in 5 strengths and forms.
Who makes Delflex?
Fresenius Medcl holds the FDA application for Delflex (NDA018883, approved November 30, 1984). 1 other company (repackagers or distributors) also list Delflex products.
Is there a generic or store brand of Delflex?
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 Delflex product.
Has Delflex been recalled?
FDA enforcement reports list 9 recalls of Delflex products; the newest started June 18, 2024. A recall usually concerns specific lots, not every product.

What Delflex is

Each Delflex 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 18.4 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
solution (intraperitoneal)		 Delflex 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
solution (intraperitoneal)		 Delflex 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
solution (intraperitoneal)		 Delflex None listed DailyMed
calcium chloride 25.7 mg/100 mL · dextrose monohydrate 1.5% · magnesium chloride 15.2 mg/100 mL · sodium chloride 567 mg/100 mL · sodium lactate 392 mg/100 mL
solution (intraperitoneal)		 Delflex None listed DailyMed
calcium chloride 25.7 mg/100 mL · dextrose monohydrate 2.5% · magnesium chloride 15.2 mg/100 mL · sodium chloride 567 mg/100 mL · sodium lactate 392 mg/100 mL
solution (intraperitoneal)		 Delflex 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 Delflex products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA018883Fresenius MedclNovember 30, 19842
NDA020171Fresenius MedclAugust 19, 19926

Companies that list Delflex

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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

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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