Methotrexate Injection Recalled Due to Presence of Glass Particulates

November 02, 2010

Sandoz and the FDA notified health-care professionals of a recall of methotrexate injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage presentations.

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. Many health-care professionals also use methotrexate for the treatment of IBD.

Customers and patients should immediately discontinue use of this product, and patients should contact their physician or health-care provider if they experience any problem that might be related to the use of this product. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

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