BEUDAMED
    FDA Recall Terminated

    Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.

    Recall: Z-0820-05 · Initiated April 22, 2005

    Recall

    Recall Number
    Z-0820-05
    Event Number
    31780
    Firm
    Kingswood Laboratories, Inc
    FEI Number
    1827505
    Product Code
    LFD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 22, 2005
    Posted
    May 11, 2005
    Terminated
    September 30, 2005
    Address
    10375 Hague Rd, Indianapolis, IN, 46256-3316

    Description

    Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.

    Reason

    Contaminated with Aspergillus and Penicillum molds.

    Action

    The firm issued a press release on 4/22/05 instructing consumers to not use the product and to return it to them. Consignees were notified via letter dated 4/22/05.

    Distribution

    Nationwide.

    Quantity

    3026 cases