TGA Suspends Pan Pharmaceuticals' Production License 32257

TGA Suspends Pan Pharmaceuticals' Production License

COLLAROY BEACH, Australia--Pan Pharmaceuticals isthe subject of an extensive regulatory action by the Therapeutic GoodsAdministration (TGA), the Australian equivalent of the U.S. Food and DrugAdministration (FDA). TGA suspended the company's manufacturing license for sixmonths and identified more than 200 products for immediate recall. The company'sapproval to supply export products was also cancelled.

According to a TGA release, the suspension followed audits ofthe manufacturing facilities, which revealed "widespread and seriousdeficiencies and failures in the company's manufacturing and quality controlprocedures, including the systematic and deliberate manipulation of qualitycontrol test data." TGA's move follows a consumer recall of anover-the-counter (OTC) product in January 2003; faulty batches of a travelsickness tablet caused 87 reported adverse drug reactions, with 19hospitalizations.

The April 28 recall action affects all batches of nutritionalproducts produced since May 1, 2002; 219 products have been identified so far.TGA is working with companies that were using Pan Pharmaceuticals for contractmanufacturing to identify additional products for recall, which could push thenumber of products involved into the area of several thousands. TGA (www.health.gov.au/tga)is posting details about the recall online with updates on affected products.The agency is also notifying overseas health agencies, such as FDA, about theactions, as the company did extensive business manufacturing for distribution inAsia, Europe and the United States.

Pan Pharmaceuticals (www.panpharmaceuticals.com)is Australia's largest contract manufacturer of natural health products,including herbal, vitamin, mineral and specialty supplements. It also producessome pharmaceutical and OTC products. Pan Pharmaceuticals has not issued astatement about the recall; however, a spokesman for the company told INSIDERit would pursue all possible appeal processes.