BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0856-2022 · Initiated February 21, 2022

    Recall

    Recall Number
    Z-0856-2022
    Event Number
    89687
    Firm
    SA3, LLC
    FEI Number
    3015256319
    Product Code
    OLR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 21, 2022
    Terminated
    May 15, 2024
    Address
    2317 Cotner Ave, Los Angeles, CA, 90064-1803

    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).

    Action

    On 02/21/2022, the firm emailed an Urgent Recall Notification to customers informing them that the recall has been initiated due to the affected lot's microbial testing results for total aerobic microbial count (TAMC exceeded specifications prior to expiry of the gel. Customer are instructed to: 1. Immediately examine your inventory and quarantine product subject to this recall. 2. Immediately discontinue use and distribution of the identified lot number. 3. To request a prepaid shipping label, complete and return the enclosed Customer Market Withdrawal Return Response Form via email at [email protected] or via fax at 888-502-1669. 4. If customer have further distributed this product to other wholesalers or pharmacies, please identify and notify them at once of this product market recall. The Recall notification and return response form should be include when notifying these customers. 5. Return the affected product to: Alexso, Inc. c/o Recall 2317 Cotner Ave Los Angeles, CA 90064 For any questions, contact the Recalling Firm at (888)-495-6078, Monday through Friday 9:00 AM to 5:00 PM PST or email at [email protected]. On 03/07/2022, the firm emailed an updated "URGENT: Medical Device Market Removal" letter which informs customers of the potential risks/harms/hazards associated with use of the affected products and added that it is recommended that physicians monitor their patents for potential adverse reactions and events as a result of use of the affected product.

    Distribution

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

    Quantity

    156 units