Recall report: Teva's chemotherapy drug recalled after investigators find particulates inside vials
A chemotherapy drug from Teva Pharmaceuticals has been voluntarily recalled after a complaint from a pharmacy that particulate was found inside a glass vial.
The company identified two particulates in a vial of topotecan injection: grey silicon particle and a translucent, colorless cotton fiber, the FDA said. One lot, with an expiration date of April 2022, has been recalled. The lot has a dosage of 4 mg/4 mL (1 mg/mL).
“The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material,” the report from the FDA said. “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 injection is used for the treatment of ovarian cancer and small cell lung cancer, as well as Stage IV-B, recurrent or persistent cervical cancer. The product from this lot was distributed to six wholesale customers, which were notified on June 18.