BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 11, 2025

    Recall

    Recall Number
    Z-2012-2025
    Event Number
    97007
    Firm
    RECORDATI RARE DISEASES INC.
    FEI Number
    3027554269
    Product Code
    LFD
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 11, 2025
    Posted
    June 23, 2025
    Address
    440 Us Highway 22, Ste 205, Bridgewater, NJ, 08807-2477

    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

    Action

    Recordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter. Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory. Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.

    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)