BEUDAMED
    FDA Recall Terminated

    B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).

    Recall: Z-0909-05 · Initiated March 25, 2005

    Recall

    Recall Number
    Z-0909-05
    Event Number
    31500
    Firm
    Harmony Brands Llc
    FEI Number
    3003990373
    Product Code
    LCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2005
    Posted
    June 21, 2005
    Terminated
    April 17, 2007
    Address
    13240 Capital St, Oak Park, MI, 48237-3159

    Description

    B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).

    Reason

    Lack of assurance of safety and efficacy; products are from unknown sources.

    Action

    Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.

    Distribution

    United States .

    Quantity

    unknown.