Bedford Laboratories announces a nationwide voluntary recall for the following three lots of Cytarabine for Injection, USP:
Cytarabine for Injection, USP 1 gram per vial – NDC ?55390-133-01
— Lot 2066986 – Exp. Date March 31, 2014
— Lot 2111675 – Exp. Date December 31, 2013
— Lot 2131148 – Exp. Date May 31, 2014
This voluntary 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. To date, there have been no reports of any adverse events for the lots being recalled. Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful 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.
Initial recall notification of the Cytarabine for Injection lots listed above were sent to impacted wholesalers and distributors by overnight courier and arranged for return of all recalled product.
Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed above for patient care and should immediately quarantine any product for return. Should wholesalers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800.562.4797.
Bedford Laboratories has informed the U.S. Food and Drug Administration (FDA) of its actions and is maintaining ongoing discussion with the agency. This voluntary recall is being conducted with the knowledge of the FDA.