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.
###
Leave a Reply