BEUDAMED
    FDA Recall Terminated

    Premier Rotaclone, Rx only

    Recall: Z-0552-2022 · Initiated December 1, 2021

    Recall

    Recall Number
    Z-0552-2022
    Event Number
    89165
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LIQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 1, 2021
    Terminated
    February 13, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Premier Rotaclone, Rx only

    Reason

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

    Action

    Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.

    Distribution

    US Nationwide distribution in the states of California and Massachusetts.

    Quantity

    34 units