BEUDAMED
    FDA Recall Terminated

    Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

    Recall: Z-1635-2010 · Initiated April 16, 2010

    Recall

    Recall Number
    Z-1635-2010
    Event Number
    55407
    Firm
    Ferring Pharmaceuticals Inc
    FEI Number
    1000119907
    Product Code
    MOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 16, 2010
    Posted
    May 21, 2010
    Terminated
    July 27, 2010
    Address
    4 Gatehall Dr, Fl 3rd, Parsippany, NJ, 07054-4518

    Description

    Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

    Reason

    Out of Specification results for molecular weight or viscosity through the established expiration date.

    Action

    Ferring Pharmaceuticals issued a "Medical Device Recall" notification dated April 16, 2010 by Federal Express to all distributors, retail pharmacies and physicians who received the product. Consignees were asked to stop distribution, return affected product to the firm and fax a completed Product Inventory Form to the firm. For further information, contact Ferring Pharmaceuticals at 1-973-796-1600 or via fax at 1-973-796-1660.

    Distribution

    Nationwide distribution.

    Quantity

    29,376 cartons with 3 syringes per carton.