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Teva Recalls One Lot of Topotecan

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Article

While the risk of exposure is low, it presents a severe hazard.

Teva Pharmaceuticals has initiated a voluntary recall of one lot of topotecan injection 4 mg/4 mL. This lot, 31328962B, was recalled after several particles, including glass, silicone and cotton fiber, were found.

Topotecan Injection is used to treat 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.

In a letter to customers, Teva officials said the particles are too large to pass through an adaptor/device into an intravenous infusion bag. But the possibility of the other particles reaching the final solution for intravenous infusion could not be excluded. While the likelihood of exposure to impacted product was determined to be remote or unlikely, the severity of the potential hazard was assessed as severe and could result in hospitalization.

This lot was shipped from September 25, 2020, through March 12, 2021.

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