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...]

      Merck Animal Health Expands Voluntary Recall with Four Additional Lots of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) in the U.S., Due to Presence of Particulate Matter

      Summary Company Announcement Date: September 29, 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 / Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein

Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein

February 25, 2019 By The FDA Leave a Comment

Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

Risk Statement: Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Health risks of ingesting phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, Golean Detox USA  has not received any reports of adverse events related to this recall.

This tainted product is marketed as a dietary supplement for weight loss and is packaged in 14 packets containing 2 capsules per packet, a total of 28 capsules per box, UPC 8 938510 909013. Golean DETOX capsules were sold Nationwide in the USA to customers on Facebook at www.goleandetoxus.com.

Golean Detox USA is notifying its customers that have the Golean DETOX capsules and is arranging for return of all recalled products. Consumers that have Golean DETOX capsules should  stop use and return the product.

Consumers with questions regarding this recall can contact Golean Detox USA by phone 704-537-2595 or [email protected] Monday – Thursday, EST, 4:00 pm to 6:00 pm.

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.

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

###

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

Merck Animal Health Expands Voluntary Recall with Four Additional Lots of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) in the U.S., Due to Presence of Particulate Matter

September 28, 2023 By The FDA

Future Motion Recalls Onewheel Self-Balancing Electric Skateboards Due to Crash Hazard; Four Deaths Reported

September 28, 2023 By The CPSC

Dick Taylor Craft Chocolate Issues Recall for Allergy Allert on Undeclared Peanuts in “Ginger Snap Milk Chocolate”

September 27, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Procter & Gamble Recalls Zevo Fly, Gnat and Fruit Fly Insect Spray Due to Injury and Laceration Hazards

September 27, 2023 By The CPSC

Nutraceutical Recalls Solaray Liposomal Multivitamins Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

September 27, 2023 By The CPSC

Rust-Oleum Recalls Fluorescent Pink Spray Paint Due to Injury Hazard

September 27, 2023 By The CPSC

Secura Recalls Air Fryers Due to Fire and Burn Hazards (Recall Alert)

September 27, 2023 By The CPSC

Polaris Recalls Ranger Recreational Off-Highway Vehicles and Pro XD Utility Vehicles, Gravely ATLAS Utility Vehicles, and Bobcat Utility Vehicles Due to Injury Hazard (Recall Alert)

September 27, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Secura Recalls Air Fryers Due to Fire and Burn Hazards (Recall Alert)

September 27, 2023 By The CPSC

Polaris Recalls Ranger Recreational Off-Highway Vehicles and Pro XD Utility Vehicles, Gravely ATLAS Utility Vehicles, and Bobcat Utility Vehicles Due to Injury Hazard (Recall Alert)

September 27, 2023 By The CPSC

SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

September 26, 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

  • Merck Animal Health Expands Voluntary Recall with Four Additional Lots of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) in the U.S., Due to Presence of Particulate Matter
  • Future Motion Recalls Onewheel Self-Balancing Electric Skateboards Due to Crash Hazard; Four Deaths Reported
  • Dick Taylor Craft Chocolate Issues Recall for Allergy Allert on Undeclared Peanuts in “Ginger Snap Milk Chocolate”
  • Penzeys Spices Issues Allergy Alert on Undeclared Sesame Seeds in “Brady Street Cheese Sprinkle”
  • Trek Recalls Allant+ 7 Bicycles Due to Crash Hazard
  • Procter & Gamble Recalls Zevo Fly, Gnat and Fruit Fly Insect Spray Due to Injury and Laceration Hazards
  • Nutraceutical Recalls Solaray Liposomal Multivitamins Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
  • Rust-Oleum Recalls Fluorescent Pink Spray Paint Due to Injury Hazard
  • Secura Recalls Air Fryers Due to Fire and Burn Hazards (Recall Alert)
-- 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