Janssen-Cilag has announced that it is working with regulatory authorities in five countries (including UK) to address trace amounts of a fungicide TBA (2,4,6 tribromoanisole) identified in five batches of darunavir (Prezista®). This follows the receipt of four consumer reports of an uncharacteristic (“musty, mouldy”) odour, which the company has determined is likely caused by trace amounts of TBA found in bottles sourced from a common supplier. As discussions with regulatory authorities continue, the company is recalling and replacing any affected bottles of product remaining in the marketplace (estimated to be < 2000 in total in countries where recalls have been initiated). Discussions with the European Medicines Agency has resulted in agreement on a Class II recall at the wholesale and retail (pharmacy) level. The company does not anticipate a product shortage resulting from its recall and replacement of affected product.

Patients are advised not to stop taking their medication. Anyone experiencing an uncharacteristic odour associated with darunavir 400mg or 600mg tablets - or anyone with questions about the company’s actions to recall and replace - should contact the company on 0800 032 3013,

In the UK, only Prezista® 400mg (bottle of 60 tablets, product code: 386471, lot number: AFZ0C00, expiry May 2012) is affected. The 75mg, 150mg and 300mg tablets are not subject to this action.