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Methotrexate Recall Initiated by Sandoz
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.
For the 50mg / 2mL vials of Methotrexate:
NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)
Parenta labels with lot numbers, 92395606, 92760803, 92965104, 92965106, 92965904, 93255704, 93502204, 93635404, 93681704
Sandoz labels with lot numbers, 93794904, 95198604, 95357804, 95537704, 95987004
For the 250mg / 10mL vials of Methotrexate:
NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)
Parenta labels with lot numbers, 92395703, 92760903, 92965203, 92966003, 93255803, 93502303, 93635503
Sandoz labels with lot numbers, 93795003, 95198703, 95357903
Pharmacies, distributors, and wholesalers will receive letters letting them known about the recall. If you, as a patient, have any of the recalled products in your possession, Sandoz asks that you 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.
