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...]

      Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone

      Summary Company Announcement Date: January 27, 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 / Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

October 10, 2018 By The FDA Leave a Comment

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

The Center for Biologics Evaluation and Research (CBER), a division of the Food & Drug Administration (FDA), which oversees human cells and tissue-based products, contacted Liveyon on Thursday, September 28, 2018. CBER stated concerns related to the products manufactured by Genetech and informed Liveyon of reported possible adverse reactions due to the use of the ReGen Series® product. Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions. In addition, Liveyon voluntarily recalled any Genetech products it may have distributed.

Working closely with the FDA, Liveyon has executed a strategic recall action plan and has immediately begun the voluntary recall process. The decision to stop shipment of Genetech products and implement the recall was to ensure the safety of all patients, regardless of whether the adverse reactions were product- related or the result of any procedural misuse of the product.

Liveyon immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. Liveyon has secured a manufacturer which has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. The new manufacturer is a US-based, FDA registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB). It is a member of the Be The Match Program and has passed all FDA inspections.

Liveyon will resume distribution of the new product line effective Monday, October 8, 2018.

###

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

Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone

January 27, 2023 By The FDA

Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll

January 26, 2023 By The FDA

ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning

January 25, 2023 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz

January 25, 2023 By The FDA

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

January 20, 2023 By The FDA

Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard; Sold Exclusively at Williams-Sonoma

January 18, 2023 By The CPSC

Sakar International Recalls Multi-Purpose Helmets Due to Risk of Head Injury

January 18, 2023 By The CPSC

Vaenait Baby Recalls Children’s Robes Due to Violation of Federal Flammability Standards and Burn Hazard

January 18, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Sakar International Recalls Multi-Purpose Helmets Due to Risk of Head Injury

January 18, 2023 By The CPSC

Vaenait Baby Recalls Children’s Robes Due to Violation of Federal Flammability Standards and Burn Hazard

January 18, 2023 By The CPSC

Vanessa Fire Tables Recalled Due to Fire Hazard; Imported by Ove Decors

January 18, 2023 By The CPSC

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

  • Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone
  • Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
  • ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning
  • Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard
  • Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging
  • Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz
  • SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products
  • Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard; Sold Exclusively at Williams-Sonoma
  • Sakar International Recalls Multi-Purpose Helmets Due to Risk of Head Injury
-- 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