US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      KELLY ( 22T010000 )

      Dated: JUN 23, 2022 Goodyear Tire & Rubber Company (Goodyear) is recalling certain Kelly Armorsteel KDM I tires, size 11R22.5 with DOT date code 3419. … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

January 16, 2018 By The FDA Leave a Comment

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.

NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.

The expanded recall affects the following lots:

Product Code Product Description Lot Number Expiration Date NDC
2G3451 NEXTERONE (amiodarone HCl) Premixed Injection, 150 mg/100 mL NC109123 5/2019 43066-150-10
2G3451 NEXTERONE (amiodarone HCl) Premixed Injection, 150 mg/100 mL NC109925 6/2019 43066-150-10

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail user level. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7 a.m. and 6 p.m. Central Time.

Customers with questions regarding this recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday through Friday, between 8 a.m. and 5 p.m. Central Time. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Baxter is voluntarily conducting this recall with the knowledge of the U.S. Food and Drug Administration.

Original Recall

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a Reply Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

KELLY ( 22T010000 )

July 7, 2022 By NHTSA

FORD ( 22V454000 )

July 7, 2022 By NHTSA

CUSTOM FIRE ( 22V461000 )

July 7, 2022 By NHTSA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

HYUNDAI ( 22V459000 )

July 7, 2022 By NHTSA

Bumble Bee Foods, LLC Issues Voluntary Recall on 3.75 Oz Smoked Clams Due to the Presence of Detectable Levels of PFAS Chemicals

July 6, 2022 By The FDA

FCCC ( 22V460000 )

July 6, 2022 By NHTSA

FREIGHTLINER ( 22V456000 )

July 6, 2022 By NHTSA

Primal Pet Foods Voluntary Recalls a Single Lot of Raw Frozen Patties Beef Formula Due to Potential Contamination with Listeria Monocytogenes

July 5, 2022 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

FREIGHTLINER ( 22V456000 )

July 6, 2022 By NHTSA

Primal Pet Foods Voluntary Recalls a Single Lot of Raw Frozen Patties Beef Formula Due to Potential Contamination with Listeria Monocytogenes

July 5, 2022 By The FDA

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

July 4, 2022 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • KELLY ( 22T010000 )
  • FORD ( 22V454000 )
  • CUSTOM FIRE ( 22V461000 )
  • GREAT DANE ( 22V448000 )
  • LINCOLN ( 22V455000 )
  • HYUNDAI ( 22V459000 )
  • Bumble Bee Foods, LLC Issues Voluntary Recall on 3.75 Oz Smoked Clams Due to the Presence of Detectable Levels of PFAS Chemicals
  • FCCC ( 22V460000 )
  • FREIGHTLINER ( 22V456000 )
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2022 Altrumedia · Terms of Service · Log in