Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

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Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4 mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on 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 (1) grey silicone particle and one (1) translucent, colorless 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. 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. 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. To date Teva has received no further complaints or reports of illness or injury.