The FDA has announced that Sandoz is conducting a voluntary nationwide recall of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the U.S. The recall was initiated after particulate matter in vials was discovered during routine quality examination of retention samples at the manufacturer. According to the FDA, injection of methotrexate from the affected lots can lead to formation of a microembolus (small obstruction) in areas where the particles lodge. Clinical symptoms are not to be expected from the microemboli and Sandoz is not aware of any reports of related adverse events.
The lot numbers and expiration dates of the two recalled lots are CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). The lots were distributed across the U.S. and to Poland. For more information or if you have questions, check out the FDA MedWatch report.