BEUDAMED
    FDA Enforcement Class II Terminated

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    Recall: Z-0856-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0856-2022
    Event ID
    89687
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SA3, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 13, 2022
    Initiation Date
    February 21, 2022
    Classification Date
    April 4, 2022
    Termination Date
    May 15, 2024
    Address
    2317 Cotner Ave, Los Angeles, CA, 90064-1803, United States

    Description

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    Reason

    Due to failure of microbial testing for total aerobic microbial count (TAMC).

    Code Info

    Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A

    Distribution

    U.S. Nationwide distribution in the states of CA, FL and GA.

    Quantity

    156 units