December 17, 2020
Shilpa Medicare Limited is voluntarily recalling more than 2000 vials of busulfan injection, citing deviations from good manufacturing practices. The recall appeared in the December 16, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall is for 10-mL single-dose vials of busulfan injection, 60 mg/10 mL (6 mg/mL), for intravenous infusion only (vial NDC 72485-210-01, carton NDC 72485-210-08) from lot 7S10008B (Exp. 12/31/20). The vials were manufactured by Shilpa Medicare Limited and distributed by Armas Pharmaceuticals Inc. throughout the United States.
Shilpa Medicare Limited initiated the recall November 17, 2020. The FDA designated it Class II December 9, 2020. Use of medications under Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Azacitidine is a chemotherapy medication used as pretreatment for patients undergoing stem cell transplant for chronic myelogenous leukemia.