Janssen issues warning on potential non-toxic contamination of Prezista 400mg or 600mg tablets

Keith Alcorn
Published: 11 May 2011

Janssen, the manufacturer of the HIV protease inhibitor Prezista (darunavir), has issued a warning to pharmacists and patients regarding the potential contamination with wood preservative of approximately 2000 bottles of Prezista 400mg or 600mg tablets supplied to five countries.

If patients notice a musty, mouldy smell when handling or opening a bottle of Prezista 400mg or 600mg tablets they are asked to contact their HIV pharmacist immediately, but not to stop taking the medication. Alternatively patients in the United Kingdom may contact Janssen on 0800 032 3013.

In the United Kingdom the problem is linked only to 400mg tablets.

The problem is caused by a chemical called TBA which is present in wood preservative, and which has been detected in 'trace amounts' in a small number of bottles. The chemical contamination is thought to have come from wood pallets on which goods are transported and stored, and is related to batches handled by one supplier.

Four patients taking Prezista have reported temporary gastrointestinal symptoms which may be related to exposure to the chemical.

As a precaution, Janssen has recalled five batches of Prezista 400mg or 600mg tablets supplied to pharmacies in the United Kingdom, Ireland, Germany, Austria and Canada, all of which were handled by the same supplier.

The recall does not apply to Prezista 75mg, 150mg and 300mg tablets.