Bedford Laboratories is recalling three lots of the cancer treatment Cytarabine for Injection, USP, I Gram per Vial, because the vials may not be sterile. This risk was determined following a post-release investigation of the manufacturing area.
Cytarabine is used in combination with other approved anticancer drugs to induce remission in acute non-lymphocytic leukemia of adults and children. It is also used in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal leukemia.
There have been no adverse events associated with the recalled lots of cytarabine injection. Bedford Laboratories has informed the Food and Drug Administration (FDA) of this recall and is maintaining ongoing discussion with the agency regarding this matter.
Hospitals, emergency rooms, clinics, physician offices, and other health care facilities and providers, or patients with product quality compliance, medical or other questions concerning the use of the product or reasons for this recall should contact the Client Services Department at 800-562-4797 between 8 a.m. and 5 p.m. EST Monday-Friday.
Any side effects experienced with any of the recalled lots should be reported to the FDA Adverse Event Reporting Program at www.FDA.gov/MedWatch.report.htm.