D-0663-2020 Class II Terminated

Recalled by Assurance Infusion — Houston, TX

Recall Details

Product Type
Drugs
Report Date
January 22, 2020
Initiation Date
December 20, 2019
Termination Date
October 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 droppers

Product Description

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

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