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Drug company (FDA labeler)

Baxter Healthcare Corp

Name in FDA records: Baxter Healthcare CORP

NDC labeler code: 0338

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
1Products (NDC)
1FDA applications
82Recalls

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ApprovedApplicationMedicineSponsor
October 7, 1975NDA017643 I.v. fat emulsion
INTRALIPID 10%		Fresenius

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

Recall timeline

2026

  1. August 17, 2026 · Class I · Ongoing · D-0849-2026 · Sodium chloride

    Presence of particulate matter: Particulates identified as fiberglass

    0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03

  2. August 6, 2026 · Class II · Ongoing · D-0812-2026 · Pantoprazole sodium

    CGMP Deviations

    Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-96

  3. August 6, 2026 · Class II · Ongoing · D-0806-2026 · Insulin human

    CGMP Deviations

    MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.

  4. August 6, 2026 · Class II · Ongoing · D-0815-2026 · Clindamycin

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.

  5. August 6, 2026 · Class II · Ongoing · D-0816-2026 · Clindamycin

    CGMP Deviations

    Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-95

  6. August 6, 2026 · Class II · Ongoing · D-0808-2026 · Clindamycin

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.

  7. August 6, 2026 · Class II · Ongoing · D-0811-2026 · Vasopressin

    CGMP Deviations

    Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.

  8. August 6, 2026 · Class II · Ongoing · D-0809-2026 · Famotidine

    CGMP Deviations

    Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-

  9. August 6, 2026 · Class II · Ongoing · D-0805-2026 · Vancomycin

    CGMP Deviations

    Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

  10. August 6, 2026 · Class II · Ongoing · D-0817-2026 · Clindamycin

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4

  11. August 6, 2026 · Class II · Ongoing · D-0820-2026 · Vancomycin

    CGMP Deviations

    Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.

  12. August 6, 2026 · Class II · Ongoing · D-0819-2026 · Vasopressin

    CGMP Deviations

    Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.

  13. August 6, 2026 · Class II · Ongoing · D-0810-2026 · Dexmedetomidine

    CGMP Deviations

    Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.

  14. August 6, 2026 · Class II · Ongoing · D-0821-2026 · Daptomycin

    CGMP Deviations

    Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC

  15. August 6, 2026 · Class II · Ongoing · D-0807-2026 · Daptomycin

    CGMP Deviations

    Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015

  16. July 24, 2026 · Class I · Ongoing · D-0787-2026 · Cefazolin

    Presence of Particulate Matter

    Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 6001

2025

  1. December 22, 2025 · Class II · Ongoing · D-0296-2026 · Water

    Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

    Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

2024

  1. August 1, 2024 · Class I · Ongoing · D-0649-2024 · Heparin sodium

    Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

    Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

  2. January 23, 2024 · Class II · Ongoing · D-0336-2024 · Norepinephrine bitartrate

    Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

    Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20

2023

  1. August 24, 2023 · Class II · Terminated · D-0048-2024 · Doxorubicin hydrochloride

    CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

    Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01

2022

  1. April 13, 2022 · Class II · Terminated · D-1119-2022 · I.v. fat emulsion

    cGMP deviations: Temperature abuse

    Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09

  2. April 13, 2022 · Class II · Terminated · D-1120-2022 · I.v. fat emulsion

    cGMP deviations: Temperature abuse

    Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-58

  3. April 13, 2022 · Class II · Terminated · D-1031-2022 · Water

    cGMP deviations: Temperature abuse

    Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06

2019

  1. November 19, 2019 · Class II · Terminated · D-0517-2020 · Sodium chloride

    Lack of Assurance of Sterility: Product has the potential to leak.

    0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29

  2. July 18, 2019 · Class II · Terminated · D-1514-2019 · Sodium chloride

    Lack of Assurance of Sterility: Bags have potential to leak.

    0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

2018

  1. September 6, 2018 · Class II · Terminated · D-1190-2018 · Sodium chloride

    cGMP Deviation

    0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31

  2. August 21, 2018 · Class II · Terminated · D-1128-2018 · Sodium chloride

    CGMP Deviations

    0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18

2017

  1. September 15, 2017 · Class I · Terminated · D-0030-2018 · I.v. fat emulsion

    Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.

    Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58

  2. July 6, 2017 · Class II · Terminated · D-0973-2017 · Sodium chloride

    Lack of Assurance of Sterility: Bags have the potential to leak.

    0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38

  3. July 6, 2017 · Class II · Terminated · D-0972-2017 · Dextrose monohydrate

    Lack of Assurance of Sterility: Bags have the potential to leak.

    5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

  4. July 6, 2017 · Class II · Terminated · D-0957-2017 · Sodium chloride

    Lack of Assurance of Sterility: Customer complaints for leaking bags.

    0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322,

  5. May 15, 2017 · Class II · Terminated · D-0789-2017 · Milrinone lactate

    Lack of assurance of sterility: customer complaints received for the presence of leaks.

    Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48

  6. May 15, 2017 · Class II · Terminated · D-0788-2017 · Fluconazole

    Lack of assurance of sterility: customer complaints received for the presence of leaks.

    Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48

2016

  1. December 6, 2016 · Class II · Terminated · D-0206-2017 · Fluconazole

    Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

    Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

  2. December 6, 2016 · Class II · Terminated · D-0425-2017 · Leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride

    Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

    10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06

  3. February 5, 2016 · Class II · Terminated · D-0731-201 · Sodium chloride

    PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.

    0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03

  4. January 21, 2016 · Class I · Terminated · D-0863-2016 · Metronidazole

    Presence of Particulate Matter: identified as a cloth fiber.

    Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

  5. January 21, 2016 · Class I · Terminated · D-0862-2016 · Sodium chloride

    Presence of Particulate Matter: identified as cardboard.

    0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

  6. January 21, 2016 · Class II · Terminated · D-0861-2016 · Sodium chloride

    Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

    0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

  7. January 21, 2016 · Class I · Terminated · D-0864-2016 · Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose, Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose

    Presence of Particulate Matter: identified as dried skin.

    CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Inject

2015

  1. December 15, 2015 · Class I · Terminated · D-0957-2016 · Sodium chloride

    Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

    0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02

  2. December 15, 2015 · Class I · Terminated · D-0958-2016 · Dextrose monohydrate

    Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

    Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-071

  3. September 2, 2015 · Class II · Terminated · D-1816-2015 · Sodium chloride

    Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.

    0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38

  4. July 17, 2015 · Class I · Terminated · D-1336-2015 · Sodium chloride

    Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

    0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.

  5. July 17, 2015 · Class I · Terminated · D-1335-2015 · Sodium chloride

    Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

    0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

  6. July 2, 2015 · Class II · Terminated · D-1326-2015 · Sodium chloride

    Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.

    0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

  7. June 3, 2015 · Class II · Terminated · D-1131-2015 · Heparin sodium

    Subpotent Drug; out of specification results for heparin raw material

    Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

  8. March 24, 2015 · Class I · Terminated · D-1208-2015 · Sodium chloride

    Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

    0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy De

  9. March 24, 2015 · Class I · Terminated · D-1209-2015 · Dextrose monohydrate

    Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

    5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL

  10. March 24, 2015 · Class I · Terminated · D-1210-2015 · Dextrose monohydrate

    Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

    10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL

  11. March 24, 2015 · Class I · Terminated · D-1211-2015 · Sodium chloride, sodium lactate, potassium chloride, and calcium chloride

    Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

    Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield

  12. March 23, 2015 · Class II · Terminated · D-0429-2015 · Sodium chloride

    Lack of Assurance of Sterility; increased complaints received for leaks

    0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

  13. March 23, 2015 · Class II · Terminated · D-0428-2015 · Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose, Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose

    Lack of Assurance of Sterility; increased complaints received for leaks

    Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC

  14. March 18, 2015 · Class II · Terminated · D-0425-2015 · Sodium chloride

    Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

    0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Co

  15. March 18, 2015 · Class II · Terminated · D-0426-2015 · Dextrose monohydrate

    Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

    5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation

2014

  1. December 23, 2014 · Class II · Terminated · D-0380-2015 · Fluconazole

    Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

    Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, I

  2. December 4, 2014 · Class I · Terminated · D-481-2015 · Sodium chloride

    Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

    0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.

  3. November 25, 2014 · Class II · Terminated · D-0301-2015 · Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose, Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose

    Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

    Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

  4. November 10, 2014 · Class II · Terminated · D-0256-2015 · Potassium chloride

    Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

    Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

  5. October 30, 2014 · Class II · Terminated · D-0276-2015 · Heparin sodium

    Subpotent Drug: Heparin raw material was found to have low potency

    Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Hea

Showing the newest 60 of 82.

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 →