Three lots of the antineoplastic drug cytarabine have been recalled because they may not be sterile, according to a posting on the Food and Drug Administration’s MedWatch site.
The nationwide recall applies to lots of cytarabine for injection (1 gm/vial), manufactured by Bedford Laboratories. The risk for lack of sterility was determined from an investigation of the manufacturing area, after the product was released, according to the FDA.
The affected lot numbers are: 2066986, 2111675, and 2131148. Any hospital, physician, clinic, or other health care facility that has any of the affected products should not use it for patients and "should immediately quarantine any product for return," the statement said. Wholesalers, distributors, or retailers that have the recalled product should stop using it and contact the company at 800-562-4797. Click here to report the product to the FDA Medwatch program.
Bedford is one of several generic manufacturers of cytarabine.
Cytarabine is approved for use in combination with other approved cancer treatments for inducing remission of acute nonlymphocytic leukemia in children and adults, and has also been found to be useful in treating acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. It is also indicated in the prophylaxis and treatment of meningeal leukemia, administered intrathecally for this indication.
To view the notice, visit the MedWatch site.