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Fresenius Kabi recalls anastrozole tablets

Fresenius Kabi has commenced a voluntary recall of two batches of anastrozole tablets shipped to the US, after indications of contamination

Fresenius Kabi has commenced a voluntary recall of two batches of 1mg dosage breast cancer drug anastrozole tablets shipped to the US, after indications of cross contamination – the company having found other medicines in some of the bottles containing anastrozole tablets.

The German drug maker is recalling 7,192 bottles, each bottle containing 30 x 1mg tablets, which expire in May 2011. Around 105 million anastrozole tablets are sold annually in the US.

Launched just three months ago, anastrozole tablets are manufactured at Fresensius Kabi Oncology's plant in Baddi (Himachal Pradesh, India). The tablets are sold in the US through Fresenius Kabi's local unit, APP Pharmaceuticals.

An analyst with brockerage firm Sharekhan, Sapna Jhawar, estimates a moderate financial impact since the market is big and there are limited players in the oncology space. It is anticipated, however, that competitors will fill the gap left by the recall and that Fresenius will find it difficult to regain the market quickly.

The total size of the market for the medicine was said to be $917m in 2009 in the US with the medicine originally made by AstraZeneca and sold under the brand name of Arimidex.

Fresenius Kabi acquired the Delhi-based cancer drug maker by buying out the Indian promoters shares two years ago. Shortly after, they acquired APP Pharmaceuticals.

Although product recalls are common globally, such developments related to Indian drug makers have come under the spotlight, especially after 30 drugs made by the country's largest drug maker Ranbaxy at its two Indian plants have been banned for manufacturing lapses. Sun Pharma has also received two warning letters for manufacturing lapses at two of its overseas plants.

4th October 2010

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