BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.

    Recall: Z-0553-2010 · Initiated October 30, 2009

    Recall

    Recall Number
    Z-0553-2010
    Event Number
    53873
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    MRC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 30, 2009
    Posted
    December 22, 2009
    Terminated
    August 29, 2012
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.

    Reason

    The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.

    Action

    Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.

    Distribution

    U.S. Nationwide, Canada and Hong Kong

    Quantity

    159,672 bottles