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Methotrexate Injection Recalled Over Glass Flakes

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Some lots of Methotrexate Injection 50mg/2mL and 250mg/10mL vials are being recalled today by Sandoz Inc., following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

The recall involves Methotrexate Injection vials sold under the brand names Sandoz and Parenta. The Methotrexate Injection, USP, 50mg/2mL vials included in the recall bear NDC Number 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial). The Methotrexate Injection, USP, 250mg/10mL bear NDC Number 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial). A complete list of lot numbers and expiration dates are available here.

Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge. While it is unlikely, parenteral 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 administration.

Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs.

To date, Sandoz has not received any adverse event reports or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found.

This recall is being issued at the consumer level. Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Additionally, as noted in the product’s labeling, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Sandoz has sent out recall letters to inform all distributors, wholesalers and pharmacies of the voluntary recall.

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