Safety Alert: Prezista
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.
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.
But, 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.
For more information, please read what the BC Centre For Excellence in HIV/AIDS has to say (PDF format).