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Drug company (FDA labeler)

Fresenius Medical Care Holdings, Inc.

NDC labeler code: 49230

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
2Products (NDC)
1FDA applications
15Recalls

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ApprovedApplicationMedicineSponsor
November 6, 2000NDA021135 Iron sucrose
VENOFER		Am Regent

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2025

  1. May 27, 2025 · Class II · Ongoing · D-0490-2025 · Sodium chloride

    Lack of Assurance of Sterility

    0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

2024

  1. November 11, 2024 · Class II · Ongoing · D-0081-2025 · Iron sucrose

    Presence of Particulate Matter: Potential for glass delamination from the vials.

    Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-

  2. November 11, 2024 · Class II · Ongoing · D-0080-2025 · Iron sucrose

    Presence of Particulate Matter: Potential for glass delamination from the vials.

    Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01

  3. June 18, 2024 · Class II · Ongoing · D-0608-2024 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

2023

  1. December 28, 2023 · Class II · Ongoing · D-0218-2024 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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.

  2. May 23, 2023 · Class II · Terminated · D-0777-2023 · Sodium chloride

    Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

    Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

2022

  1. November 22, 2022 · Class II · Ongoing · D-0075-2023 · Sodium chloride

    Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

    0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-

  2. October 11, 2022 · Class II · Ongoing · D-0015-2023 · Sodium chloride

    Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

    0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-

2021

  1. April 28, 2021 · Class III · Terminated · D-0609-2021 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

  2. April 28, 2021 · Class III · Terminated · D-0607-2021 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

  3. April 28, 2021 · Class III · Terminated · D-0605-2021 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

  4. April 28, 2021 · Class III · Terminated · D-0610-2021 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

  5. April 28, 2021 · Class III · Terminated · D-0608-2021 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

  6. April 14, 2021 · Class II · Terminated · D-0389-2021 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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

2017

  1. December 20, 2017 · Class II · Terminated · D-0604-2018 · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

    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.

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).

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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →