Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
FDA Recall #D-0663-2020 — Class II — December 20, 2019
Product Description
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Assurance Infusion — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
32 droppers
Distribution
Nationwide within the United States
Code Information
Lots: 12092019@33 Exp. 03/08/2020; 11112019@30 Exp. 02/09/2020; 10012019@17 Exp. 12/30/2019; 10162019@18 Exp. 01/14/2020; 10252019@11 Exp. 01/23/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated