Roche, 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.
VIRACEPT is an HIV medicine called a protease inhibitor. These medicines fight the HIV virus. When used with other HIV medicines, VIRACEPT is an effective treatment against HIV. Like other HIV medications, VIRACEPT is not a cure for HIV or AIDS. But, it may help control the disease. Those who take VIRACEPT might still get infections or other illnesses linked with HIV. Viracept comes in tablets (625 mg or 250 mg) and an oral powder.