Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the U.S., due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The particulates are not associated with microbial contamination.
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. Microemboli can form in areas where the particles lodge. Following intravenous injections, microemboli are likely to form in the lung. Intrathecal injections are very unlikely with the affected product. In the event of intrathecal administration, microemboli are likely to form in the areas of spinal fluid resorption. Clinical symptoms are not to be expected from these microemboli. 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). These lots were distributed nationally across the U.S. and to a single foreign country (Poland).
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication