Sandoz Recalls Two Lots of Methotrexate Sodium, USP Due to Particulate Matter

Topics: Patient safety

Sandoz US is voluntarily recalling two lots of methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable product because of particulate matter found during a routine test of samples. FDA warns that injection of a drug with particulate matter can lead to microembolism in areas where the particles lodge. Sandoz stated that the particulates were not associated with microbial contamination. The lots being recalled are CL0996 with an expiration date of December 2013 and CJ4948 with an expiration date May 2013. Sandoz reported that the recall has been inititiated with the knowledge of FDA and that the company is not aware of any adverse reactions associated with the products.