BEUDAMED
    FDA Recall Terminated

    Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553

    Recall: Z-1082-05 · Initiated June 9, 2005

    Recall

    Recall Number
    Z-1082-05
    Event Number
    32593
    Firm
    Del Laboratories Inc.
    FEI Number
    2410781
    Product Code
    EFW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2005
    Posted
    August 3, 2005
    Terminated
    December 11, 2007
    Address
    55 West Ames Court, Suite 100, Plainview, NY, 11803

    Description

    Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553

    Reason

    Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.

    Action

    Recall letters were sent on 6/09/05 by FedEx to direct wholesalers/distributors and retailers nationwide. A nationwide press release was issued on 6/10/05, and notification sent to numerous consumer & parenting publications, plus posting on company website. Questions from consumers should be referred to Del Pharmaceuticals at 1-800-818-1915 or by email at [email protected]. Recall letters were sent to 3 direct accounts on 7/21/05 via FedEx after the discovery that these accounts had not been notified.

    Distribution

    Nationwide & Puerto Rico.

    Quantity

    134,082 units domestically, and 1578 units internationally as samples