Teva Recalls 1 Lot of Topotecan Injection

FDA says Teva has recalled one lot of topotecan injection (4mg/4mL) due to the presence of particulate matter. An agency statement says the nationwide recall to the retail/institutional level was initiated based on a complaint from a pharmacy after a single glass particle was observed inside one vial. The notice says that after further examination of the complaint sample, two other particulates were found — one gray silicone particle and one translucent, colorless cotton fiber.

The drug is indicated for treating patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small-cell lung cancer platinum-sensitive disease who progressed at least 60 days after initiation of first-line therapy. It also is indicated for treating patients with stage IV-B recurrent or persistent cervical cancer that is not amenable to curative treatment, in combination with cisplatin.