Bedford Laboratories announced 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. Healthcare providers with questions concerning the use of the product or reasons for this recall should contact the Client Services Department at 800.562.4797 between 8am and 5pm EST Monday – Friday.
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.
For more information visit www.BedfordLabs.com.