Recall: Particulate Discovered in Methotrexate Vials
Sandoz is conducting a voluntary nationwide recall of two lots of Methotrexate Sodium 25mg/mL, 40mL vial injectable product after the discovery of particulate matter in vials during quality examination.
The affected products have lot #CL0996 (Exp. 12/2013) and #CJ4948 (Exp. 5/2013). These lots were distributed nationwide across the United States and to Poland. Parenteral injection of drug from the affected lots can lead to microembolization in areas where the particles lodge.
Methotrexate is an antimetabolite used to treat various neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.
For more information call (800) 525-2492 or visit the FDA website.