Bedford Laboratories has issued a voluntary recall for three lots of Cytarabine for Injection, USP, 1 gram per vial.
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The recall is announced due to post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots, the company said.
Cytarabine in conjunction with other anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia, 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.
The FDA is intimated about the Bedford’s voluntary recall of Cytarabine.
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