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Thread: Heads Up -- Injectable Methotrexate RECALL

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  1. #1
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    Default Heads Up -- Injectable Methotrexate RECALL

    For anyone who uses injectable methotrexate, there has been a recall on some vials: http://www.fda.gov/Safety/MedWatch/S.../ucm353266.htm

    Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
    [Posted 05/21/2013]

    ISSUE: Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Clinical symptoms are not to be expected from these
    microemboli and Sandoz is not aware of any reports of related adverse events.

    BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).

  2. #2
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    Thanks for the heads up. I checked mine, they are ok, date is March 2014.

    Debbie
    I may have been dealt a bad hand, but at least I'm still playing with a full deck. ( most of the time anyway).

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