BEUDAMED
    FDA Recall Terminated

    Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz

    Recall: Z-0715-2007 · Initiated March 5, 2007

    Recall

    Recall Number
    Z-0715-2007
    Event Number
    37507
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    LYL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 5, 2007
    Posted
    April 4, 2007
    Terminated
    January 9, 2008
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz

    Reason

    A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.

    Action

    The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.

    Distribution

    Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.

    Quantity

    1.5 million units