Chemotherapy Drug Recalled

Baxter Healthcare Corporation is recalling 13,502 vials of bendamustine hydrochloride injection after a customer reported vials with peeling labels, according to the August 30, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects bendamustine hydrochloride injection, 100 mg/4 mL (25 mg/mL), in 4-mL multiple-dose vials (NDC 10019-079-01), from lots 3A004A (Exp. 12/31/24), 3A004B (Exp. 12/31/24), and 3B005A (Exp. 1/31/25). The drug was manufactured for Baxter Healthcare Corporation, Deerfield, Illinois, and distributed throughout the United States.

Baxter Healthcare Corporation voluntarily initiated the recall August 14, 2023. On August 24, 2023, the FDA designated the recall Class III. The classification communicates that use of the affected injection is not likely to cause harm.

Bendamustine hydrochloride is a chemotherapy drug indicated for the treatment of adults with chronic lymphocytic leukemia and non-Hodgkin lymphoma.