Fresenius Kabi recalls drug made by Indian arm for US sale

German drugmaker Fresenius Kabi has started voluntary recall of two batches of a cancer drug made by its Indian subsidiary Fresenius Kabi Oncology and shipped to the US, after it found cross contamination. The drug, brand-named anastrozole tablets, is used to treat breast cancer and is sold in the US through Fresenius Kabi's local unit APP Pharmaceuticals.

The drug, made at Fresensius Kabi Oncology's plant in Baddi (Himachal Pradesh), was launched just three months ago. Fresenius Kabi Oncology, formerly known as Dabur Pharma, was acquired by the German firm from the Burmans of Dabur Group in 2008.

The firm informed the US drug regulator about the recall on 1 September, the US Food and Drug Administration (FDA) said on its website. The company found other medicines in some of the bottles containing anastrozole tablets of 1 mg dosage, it said. Fresenius Kabi is recalling 7,192 bottles, each bottle containing 30 1-mg tablets, which expires in May next year.

The financial implications of the recall could not be immediately ascertained, reports said. The report quoted a person close to the company as saying it was an isolated case of some other drug mixing up in few bottles containing anastrazole.

The company is recalling both the batches as a precautionary measure and there will be no material financial impact from the recall, the newspaper's source said. So far, there have also been no complaints of adverse effects from patients and there is no quality problem with the drug, he said.

The total size of the US market for the medicine was $917 million in 2009, APP Pharmaceuticals had quoted market research firm IMS in a release at the time of the launch of the drug in end-June. Around 105 million anastrozole tablets are sold annually in the US, the release added. Fresenius Kabi is recalling around 0.2 million tablets.