Chemotherapy Agent Recalled

Teva Pharmaceuticals USA is recalling a single lot of topotecan injection after a customer reported a glass particle in one of the lot’s vials, according to the July 14, 2021, US Food and Drug Administration (FDA) Enforcement Report.

“The vial was returned to Teva for further analysis where two other particulates were found,” the FDA reported, “and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.”

The recall affects topotecan injection, 4 mg/4 mL (1 mg/mL) single-dose vials (carton NDC 0703-4714-01, vial NDC 0703-4714-71), from lot 31328962B (Exp. 4/22). The vials were distributed throughout the United States.

Teva Pharmaceuticals voluntarily initiated the recall June 18, 2021. The FDA has not yet classified the recall.

Topotecan is a chemotherapy injection used to treat cancer of the ovary, lung, and cervix.