The recall follows the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer.
Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.
Particulate matter in parenteral drugs has been recognized as a potential health hazard, according to the US Food and Drug Administration.
The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).