A drug used for cancer treatment has been voluntarily recalled according to the U.S. Food and Drug Administration (FDA).
Teva Pharmaceuticals is recalling one lot of its injectable cancer drug topotecan after a pharmacy found one of the vials contained a glass particle.
The FDA made the announcement last week that after a further examination, a silicone particle was also found in a vial as well as a cotton fiber.
“The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material,” the FDA Announcement indicated. “If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.”
Topotecan is indicated to treat metastatic ovarian cancer, small-cell lung cancer and cervical cancer.
The recalled lot was distributed nationwide to six of Teva’s wholesale customers, and the drugmaker has asked its customers to return all affected vials.
“While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient exposure to impacted product is remote or unlikely,” the FDA release said. “To date Teva has received no further complaints or reports of illness or injury.”