Sandoz and the FDA have notified healthcare professionals of a voluntary recall of Methotrexate Injection 50mg/2mL and 250mg/10mL vials that may contain small glass flakes. The flakes are the result of delamination of the glass used to manufacture the vials.

The affected lots being recalled can be found at www.us.sandoz.com/site/en/company/news/pool/methotrexate_pr.pdf

Due to the particle size, there is the potential to develop adverse reactions in areas where the particles lodge. Potential serious adverse events by the intravenous route include local damage to blood vessels in the lung, localized swelling and granuloma formation, and by the intramuscular route include foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic damage could result from intrathecal administration.

Methotrexate is indicated for the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.


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For more information call Sandoz (609) 627-5287 or visit www.fda.gov/Safety/Recalls/ucm231430.htm.