Sandoz Issues Generic Trexall Recall Due to Particulate Matter

Two lots of methotrexate, better known as generic Trexall, have been recalled after a routine examination revealed the presence of particulate matter in injection fluid vials, posing a health hazard to users.

The methotrexate sodium recall was announced by the U.S. Food and Drug Administration on May 20, which indicated that vials could allow particulate matter to become lodged in the lungs and cause severe health consequences.

Methotrexate sodium injections are commonly used during chemotherapy, for treatment of rheumatoid arthritis and psoriasis. The injection can be administered via parenteral or intrathecal injection. When administered intravenously, there may be a risk of particulate matter lodging in the lungs. Intrathecal injections administered in the spinal area may allow the particulate matter to lodge within the spinal region and cause interference with spinal fluid resorption.

The recall consists of Methotrexate Sodium USP, 25 mg/mL, 40 mL injectable vials with the following lot numbers and expiration dates; CL0996 and expiration date December 2013, and CJ4948 with expiration date May 2013.

The recalled lots were manufactured by Sandoz, a Division of the Novartis group that manufactures generic pharmaceuticals internationally. The contaminated lots were distributed across the United States and Poland for hospital and user level treatment.

Consumers are encouraged to contact their healthcare provider immediately in any event of adverse reaction and may also contact the Sandoz Drug Information Direct Line at 800-525-2492 or email the firm at qa.druginfo@sandoz.com.