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...]

      Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk

      Summary Company Announcement Date: September 25, 2023 FDA Publish Date: … [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 / Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up

Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up

August 30, 2023 By The FDA Leave a Comment

Summary

Company Announcement Date:
August 30, 2023
FDA Publish Date:
August 31, 2023
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Label Mix-Up

Company Name:
Marlex Pharmaceuticals, Inc.
Brand Name:

Brand Name(s)

Marlex Pharmaceuticals, Inc.

Product Description:

Product Description

Digoxin Tablets USP, 0.125mg and 0.25mg


Company Announcement

FOR IMMEDIATE RELEASE – August 30, 2023 – New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg.

Digoxin Tablets USP, 0.125mg are yellow, circular, beveled, uncoated tablets scored between “N” and “201” on one side and plain on the other side.

Digoxin Tablets USP, 0.25mg are white to off-white, circular. beveled, uncoated tablets scored between “N” and “202” on one side and plain on the other side.

Risk Statement: The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Patients who intend to take Digoxin Tablets USP, 0.125mg, but unknowingly Digoxin 0.25mg would receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose. Patients who intend to take Digoxin Tablets USP, 0.25mg, but unknowingly take Digoxin 0.125mg would receive a sub potent dose which may lead to loss of control of heart rate and potential heart failure exacerbation. Marlex Pharmaceuticals, Inc has not received any reports of adverse events related to this recall.

The product is used for the treatment of mild to moderate heart failure. Digoxin increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date.

Digoxin 0.125mg Tablet – NDC 10135-0747-01, lot# E3810, expiration 2/2025

Digoxin 0.25mg Tablet – NDC 10135-0748-01, lot# E3811, expiration 2/2025

Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Product were distributed Nationwide.

Consumers/distributors/retailers that have Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg (lot# E3810 and lot# E3811) which are being recalled should stop using/return to place of purchase. Marlex Pharmaceuticals, Inc. is notifying its distributors and customers by emails and is arranging for return of all recalled products (lot# E3810 and lot# E3811).

Consumers with questions regarding this recall can contact Marlex Pharmaceuticals, Inc. by phone number 302-328-3355 or toll free 888-582-1953 on Monday – Friday from 8.30AM and 4:30PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Marlex Pharmaceuticals, Inc
302-328-3355 or toll free 888-582-1953


Product Photos

  • Label for Digoxin Tablets USP, 0.125mg

  • Label for Digoxin Tablets USP, 0.25mg

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 ReplyCancel 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

Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk

September 24, 2023 By The FDA

VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 22, 2023 By The FDA

TAMA Corporation Emite Un Alerta De Alergenos No Declarados: Trigo, Soya y Amarillo #5 En Las “Cachapas De Maiz Paisa”

September 21, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Make Believe Ideas Recalls Seven Rainbow Road Board Books Due to Choking Hazard

September 20, 2023 By The CPSC

H&M Recalls Men’s Clasp Beaded Bracelets Due to Lead Poisoning Hazard; High Levels of Lead Content

September 20, 2023 By The CPSC

FXI Recalls Novaform ComfortGrande and DreamAway Mattresses Due to Risk of Mold Exposure; Sold Exclusively at Costco (Recall Alert)

September 20, 2023 By The CPSC

DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration Hazard

September 20, 2023 By The CPSC

Shimano Recalls Cranksets for Bicycles Due to Crash Hazard

September 20, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration Hazard

September 20, 2023 By The CPSC

Shimano Recalls Cranksets for Bicycles Due to Crash Hazard

September 20, 2023 By The CPSC

Life Raft Treats has Expanded their Recalls of Ice Cream Products, Not Fried Chicken And Life Is Peachy, Due to Possible Listeria Monocytogenes Contamination

September 18, 2023 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

  • Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk
  • VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
  • TAMA Corporation Emite Un Alerta De Alergenos No Declarados: Trigo, Soya y Amarillo #5 En Las “Cachapas De Maiz Paisa”
  • TAMA Corporation Issues Allergy Alert for Undeclared Wheat, Soy and Yellow #5 in “Cachapas de Maiz PAISA”
  • HONEY JOY Recalls Infant Swings Due to Suffocation Hazard and Violation of Federal Safety Standards; Sold Exclusively on Amazon.com
  • Make Believe Ideas Recalls Seven Rainbow Road Board Books Due to Choking Hazard
  • H&M Recalls Men’s Clasp Beaded Bracelets Due to Lead Poisoning Hazard; High Levels of Lead Content
  • FXI Recalls Novaform ComfortGrande and DreamAway Mattresses Due to Risk of Mold Exposure; Sold Exclusively at Costco (Recall Alert)
  • DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration Hazard
-- 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 © 2023 Altrumedia · Terms of Service · Log in