Topotekan

2021: Withdrawal of the drug due to garbage in the bottle

In early July 2021, Teva Pharmaceuticals initiated a voluntary recall of a batch of its ovarian cancer injection drug, topotecan 4 mg/4 ml (1 mg/ml). The recall is associated with a complaint about the presence of foreign particles in the bottle from the pharmacy. The study showed that a glass fragment, a drop of silicone and colorless cotton fiber fell into the bottle. Teva recalled the defective party and began an internal investigation.

According to the notification, administration of an injection product containing particulate matter may result in local irritation or swelling in response to foreign material. If the particles reach the bloodstream, they can lead to embolism of the vessels, hearts lungs or brain, brain and therefore cause a heart attack, stroke or death.

Teva recalls Topotecan drug for ovarian cancer due to garbage in a bottle

An internal assessment of Teva showed that despite a serious health hazard, the likelihood of patient contact with the defective product is small. The Company has not received new complaints or reports of the development of any illness or injury.

Topotecan as a monotherapy is indicated for the treatment of patients with metastatic ovarian cancer after disease progression following chemotherapy of the first and subsequent lines, as well as for the treatment of patients with small-cell lung cancer, in whom progression developed at least 60 days after the onset of first-line chemotherapy. This preparation in combination with cisplatin is also indicated for the treatment of patients with recurrent or treatment-resistant stage IV-B cervical cancer.

Teva distributes the drug across the United States with the help of six wholesale buyers. The company notified customers of the violations found, asked to withdraw the defective batch and take measures to return the defective products.^[1]

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