June 6, 2011 – The Pharmacovigilance Program at the BC Centre for Excellence in HIV/AIDS has reviewed the following incident: On May 11, 2011, Janssen Inc. issued an advisory that some bottles of darunavir (Prezista TM) 600 mg tablets in Lot # ALZ0J00 might have an uncharacteristic “musty” or “mouldy” odour caused by trace quantities of the wood preservative by-product 2,4,6,tribromoanisole (TBA).

Health Canada has advised the manufacturer that a product recall is NOT REQUIRED because there is no known safety risk associated with the odour-causing agent. Persons who take darunavir should continue to take their medication. Based on available information, the affected batch of darunavir tablets is safe for consumption and there is no requirement to return product or recall patients for clinical assessment. As a precautionary measure, darunavir tablets from Lot # ALZ0J00, or any darunavir tablets with an uncharacteristic odour that were dispensed in BC may be voluntarily returned to St Paul’s Hospital Ambulatory Pharmacy and exchanged for new product.