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Sandoz Initiates Methotrexate Recall

Sandoz Initiates Methotrexate Recall

Sandoz, a subsidiary of Novartis, a multinational pharmaceutical company, has initiated a voluntary recall on their drug vials of Methotrexate. The Methotrexate recall was initiated today after Sandoz found tiny glass particles may be in the vials. If injected, the glass could possible make its way into the human body, and in some cases cause major health issues, or even death. The glass particles are from delaminating of the glass used for the vials. Sandoz has stated the following in a press release just issued on the FDA website this afternoon:

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.

The vials involved in this Methotrexate recall are only the 50mg/2mL and 250mg/10mL vials. The products all expired between December of this year and March of 2012, and have the following lot numbers, labels, and NDC numbers.

Pharmacies, distributors, and wholesalers will receive letters letting them known about the recall. Sandoz asks that the customers immediately stop using them, and contact your physician for further instructions. Sandoz, which is headquartered in Holzkirchen, Germany, was founded in 2003, and currently employs over 22,000 people.

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