FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
FDA Recall #D-0129-2021 — Class II — November 30, 2020
Product Description
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling Firm
Advanced Nutriceuticals, LLC — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1 vial
Distribution
CA, CO, FL, IN, KY, OH, TX
Code Information
Lot #1112202006, Exp 12/12/2020
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated