AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
FDA Recall #D-0131-2021 — Class II — November 30, 2020
Product Description
AOD-9604, 1200 MCG/ML, 5 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
3 vials
Distribution
CA, CO, FL, IN, KY, OH, TX
Code Information
Lot #1029202003, Exp 11/29/2020; Lot #1110202002, Exp 12/10/2020; Lot #1112202001, Exp 12/12/2020
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated