Drug Safety Alerts

Topotecan Injections Voluntary Recall

7/15/2021

On July 15, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Topotecan Injection, 4 mg/4 mL, (1 mg/mL) single-use vials manufactured by Teva Pharmaceuticals USA. This recall is being issued due to the presence of particulate matter. According to Teva, a complaint was received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one grey silicone particle and one translucent, colorless cotton fiber.

This may represent a potential health hazard or safety risk to plan members using product affected by this recall.

A complete list of the affected products and lot numbers can be found here.

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. Teva reports that to date it has received no further complaints or reports of illness or injury.

Topotecan Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. It is also indicated for treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer, which is not amenable to curative treatment, in combination with cisplatin. It is packaged in 4 mg/4 mL single use vials.

Please note: This recall was issued to retail depth on June 28, 2020. On the July 15, 2021 Enforcement Report, the FDA classified this as a Class I recall.

CVS Caremark Response: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information, call Teva Pharmaceuticals USA toll-free at 1-888-838-2872, Monday through Friday from 9:00 AM to 5:00 PM (EST). You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.