Pharmaceutical Business review

Roche recalls Viracept due to chemical impurity

Roche revealed that it is carrying out the recall in agreement and cooperation with the EMEA and Swissmedic health authorities, after receiving several reports that some batches of Viracept 250mg tablets have a strange odor.

The drugmaker said that a detailed chemical analysis of the affected tablets showed that they contain higher than normal levels of methane sulfonic acid ethylester. As a result, Roche decided to recall all batches of Viracept tablets and powder in the interest of patient safety.

In a press release confirming the recall, Roche advised patients being treated with Viracept to contact their doctors to discuss alternative therapies.

Viracept, which is known generically as nelfinavir, is one of a new class of anti-HIV drugs called protease inhibitors that work by blocking a part of HIV called protease. Viracept was first introduced by Roche in 1998.