The Pharmaceutical Journal
Vol 278 No 7457 p728
23 June 2007

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Viracept recall resulted from cleaning errors

Blunders during the routine cleaning process at a manufacturing plant led to contamination of the Viracept (nelfinavir) products recalled last week (PJ, 16 June, p694).

The contamination occurred in Basel, Switzerland, ahead of manufacture of the active pharmaceutical ingredient. As a result of human error, a cleaning product reacted with ethanol, accelerating the production of a by-product, methane sulfonic acid ethyl ester, which was then present at higher than usual levels in the Viracept tablets. Staff involved in the maintenance procedures have been retrained to prevent the problem recurring.

A spokeswoman for Roche said the company is investigating all avenues to find substitute sources of Viracept and is working with Pfizer, which markets a different nelfinavir product in the US. Roche believes that no other products were affected and it estimates that 45,000 patients worldwide were taking Viracept at the time of the recall.