Roche's Chugai recalls Vesanoid in Japan

Roche's Japanese subsidiary Chugai has recalled its Vesanoid capsules for acute promyelocytic leukemia in Japan.

The recall follows the discovery of bovine-derived material sourced from Canada in a specific batch of the capsules imported from Roche, which is based in Switzerland.

Use of such material requires a partial amendment to the approval document for use in Japan.

Chugai and Roche had agreed not to export Vesanoid capsules using the material to Japan, but went ahead with the exportation anyway because Roche believed that its use was approved in the region.

Vesanoid had annual sales of approximately USD 24m for the twelve months ended April 2007, based on IMS sales data.