BEUDAMED
    FDA Enforcement Class II Terminated

    Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.

    Recall: Z-1554-2014 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1554-2014
    Event ID
    68095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Inc- Greenville Solutions Plant
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2014
    Initiation Date
    April 21, 2014
    Classification Date
    May 6, 2014
    Termination Date
    January 9, 2015
    Address
    8507 Pelham Rd, N/A, Greenville, SC, 29615-5749, United States

    Description

    Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.

    Reason

    Out of specification results for one of the two disinfectants.

    Code Info

    Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.

    Distribution

    US Nationwide.

    Quantity

    256,440 bottles