Regen Series Product, which is manufactured by Genetech, Inc., and distributed by Liveyon, LLC, is being recalled because adverse reactions have been reported to the FDA. Liveyon was notified by the Center for Biologics Evaluation and Research on Thursday, September 28, 2018 about this issue and was told about possible reported adverse reactions and concerns about products made by Genetech.
These products are made from human cells and tissues. The recall notice did not state how these products are used, or what their intended use is.
Liveyon has discontinued the purchase of any product from Genetch, suspended shipment of all product, and has found an alternative manufacturer. Meanwhile, all ReGen Series products are being recalled. Liveyon has also voluntarily recalled any Genetech products it distributed.
There is no mention of what the adverse reactions are, how many people may have been affected, patient ages, or if the reactions were serious enough to require hospitalization. The notice stated that 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.”
If you have used these products and have experienced any adverse reactions, you should see a doctor and then report your experience to the FDA. You an fill out an FDA MedWatch Adverse Reactions Reporting Form. This form will ask about your issue, if you may have used a product incorrectly, or if you were hospitalized, or had permanent harm. This form is used for problems with medicine, biologist (human cells and tissues used for transplantation), nutrition products, cosmetics, and foods.
