Teva Pharmaceuticals has recalled a single lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) due to presence of particulate matter, the U.S. Food and Drug Administration said.
The recall involves lot 31328962B of Topotecan Injection with expiry date 04/2022 to the retail/institutional level in the United States. Topotecan Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer and small cell lung cancer platinum-sensitive disease.
Teva distributed the product across the country to six of its Wholesale customers.
The recall was initiated following a complaint received from a pharmacy after a single glass particle was observed inside one vial.
After further examination of the complaint sample, two other particulates were found and identified as one grey silicone particle and one translucent, colorless cotton fiber.
According to the agency, the administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. The particulate matter can reach the blood vessels, and can travel to various organs and block blood vessels in the heart, lungs or brain that may cause stroke and even lead to death.
Meanwhile, Teva’s internal health assessment determined that the likelihood of patient exposure to impacted product is remote or unlikely.
The company has not received any further complaints or reports of illness or injury too date related to the recalled item.
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