May 11, 2011
Regulatory agencies in the United Kingdom, Canada, Ireland, Germany, and Austria are working with a J&J unit to address trace amounts of a fungicide found in the HIV drug Prezista in their respective markets. Janssen said it initiated the investigations into the five lots after it received four complaints of a musty, moldy odor in Prezista. The odor was likely caused by trace amounts of tribromoanisole (TBA), a fungicide used in packing materials, found in bottles sourced from a common supplier, Janssen said in a statement. Though a very small number of patients reported temporary gastrointestinal symptoms, there were no reports of serious adverse advents related to TBA, the company said. TBA has been linked to many of J&J's recalls over the past year and a half.