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    RA Drug Methotrexate Is Recalled

    Glass Flakes in Injectable Rheumatoid Arthritis Drug Spur Recall
    By
    WebMD Health News
    Reviewed by Laura J. Martin, MD

    Oct. 28, 2010 -- Glass flakes have led to the recall of Sandoz and Parenta brand injectable methotrexate, a drug used to treat rheumatoid arthritis, cancer, and psoriasis.

    The glass flakes "are the result of delamination of the glass used to manufacture the vials" of two dosages of the drug, the FDA says in a news release.

    "There is the potential to develop adverse reactions in areas where the particles lodge," the FDA says. "Injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal [spinal] administration."

    There have been no reports of adverse events to date.

    Customers and patients should immediately discontinue use of this product and patients should contact their doctor or health care provider if they experience any problem that might be related to the use of this product.

    Adverse events related to the use of Sandoz methotrexate product should be reported to Sandoz at 800-525-8747 or to the FDA’s MedWatch Adverse Event Reporting Program.

    The recall applies to all 50 mg/2 mL and 250 mg/10 mL vials of the drugs:

    Product : Methotrexate Injection, USP, 50 mg/2 mL
    NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)

    Lot Number Label Type Exp Date
    92395606 Parenta 12/2010
    92760803 Parenta 2/2011
    92965104 Parenta 3/2011
    92965106 Parenta 3/2011
    92965904 Parenta 4/2011
    93255704 Parenta 6/2011
    93502204 Parenta 7/2011
    93635404 Parenta 8/2011
    93681704 Parenta 8/2011
    93794904 Sandoz 9/2011
    95198604 Sandoz 10/2011
    95357804 Sandoz 12/2011
    95537704 Sandoz 1/2012
    95987004 Sandoz 3/2012



    Product : Methotrexate Injection, USP, 250 mg/10 mL
    NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)

    Lot Number Label Type Exp Date
    92395703 Parenta 12/2010
    92760903 Parenta 2/2011
    92965203 Parenta 3/2011
    92966003 Parenta 4/2011
    93255803 Parenta 6/2011
    93502303 Parenta 7/2011
    93635503 Parenta 8/2011
    93795003 Sandoz 9/2011
    95198703 Sandoz 10/2011
    95357903 Sandoz 12/2011

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