BEUDAMED
    FDA Enforcement Class II Ongoing

    Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

    Recall: Z-2012-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2012-2025
    Event ID
    97007
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RECORDATI RARE DISEASES INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 2, 2025
    Initiation Date
    June 11, 2025
    Classification Date
    June 23, 2025
    Address
    440 Us Highway 22 Ste 205, Bridgewater, NJ, 08807-2477, United States

    Description

    Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

    Reason

    Out of specification stability test result for the Caphosol B solution from process validation lots

    Code Info

    UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10

    Distribution

    Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.

    Quantity

    3,754 boxes (120,128 doses)