Bedford Laboratories announced a nationwide voluntary recall of three lots of Cytarabine for Injection, USP 1 gram per viral - NDC #55390-133-01. This market recall is being conducted due to a post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots.
Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic luekemia of adults and children. It has also been found useful in the treatment of acute lymphocytic luekemia and the blast phase of chronic myelocytic luekemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal luekemia.
Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed for patient care and should immediately quarantine any product for return.
The affected product lots are stated in the FDA recall.
See the FDA Recall