Teva Pharmaceuticals has initiated a voluntary recall of 1 lot of Topotecan Injection 4mg/4mL (1mg/mL) due to the presence of particulate matter.

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 the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin.

The recalled lot, Topotecan Injection 4mg/4mL (1mg/mL); Carton NDC# 0703-4714-01; Vial NDC# 0703-4714-71; Lot Number 31328962B; Expiration Date 04/2022, was distributed nationwide to 6 of Teva’s Wholesale customers. The recall was initiated after a complaint received from a pharmacy found a single glass particle inside 1 vial. Upon further examination of the complaint sample, 2 other particulates were identified, including 1 grey silicone particle and 1 translucent, colorless cotton fiber.

To date, Teva has not received any further complaints or adverse events reports related to this recall. According to Teva’s internal health assessment, the likelihood of patient exposure to impacted product is remote or unlikely. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.


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For more information regarding this recall contact Teva Pharmaceuticals by calling (888) 838-2872 or emailing [email protected].

Reference

Teva initiates voluntary nationwide recall of one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) due to presence of particulate matter. [press release]. Silver Spring, MD: US Food and Drug Administration; July 1, 2021.