Roche Recalls Viracept Due to Chemical Impurity
BASEL, Switzerland, 06. June 2007Roche, in agreement and cooperation with Health Authorities (EMEA and Swissmedic), recalls in Europe and some other world regions all batches of Viracept powder and tablets. The US, Canada and Japan are not affected by this recall.
Roche has received several reports that some batches of Viracept 250 mg tablets have a strange odour. A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulfonic acid ethylester. In the interest of patients safety Roche has decided to recall all batches of Viracept tablets and powder.
Patients are requested to contact their doctors to discuss alternative therapies.
Viracept (nelfinavir), a protease inhibitor is supplied by Roche outside the US and Canada. Viracept was first introduced by Roche in 1998.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our website at www.roche.com.
Posted: June 2007