BEUDAMED
    FDA Recall Terminated

    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

    Recall: Z-1382-2021 · Initiated March 23, 2021

    Recall

    Recall Number
    Z-1382-2021
    Event Number
    87600
    Firm
    Sunstar Americas, Inc.
    FEI Number
    1413787
    Product Code
    EAX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 23, 2021
    Terminated
    August 28, 2023
    Address
    301 E Central Rd, Schaumburg, IL, 60195-1901

    Description

    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

    Reason

    Product may be contaminated with Burkholderia contaminans.

    Action

    Sunstar initiated the recall by letter and email on 03/23/2021. The letter requested the consignee check their inventory and isolate affected product, then contact customer service with the results. The firm requested the return of the product. Distributors are asked to notify their customers down to the user level.

    Distribution

    US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico

    Quantity

    19471 bottles