COLLAROY BEACH, Australia--Pan Pharmaceuticals is the subject of an extensive regulatory action by the Therapeutic Goods Administration (TGA), the Australian equivalent of the U.S. Food and Drug Administration (FDA). TGA suspended the company's manufacturing license for six months and identified more than 200 products for immediate recall. The company's approval to supply export products was also cancelled.
According to a TGA release, the suspension followed audits of the manufacturing facilities, which revealed "widespread and serious deficiencies and failures in the company's manufacturing and quality control procedures, including the systematic and deliberate manipulation of quality control test data." TGA's move follows a consumer recall of an over-the-counter (OTC) product in January 2003; faulty batches of a travel sickness tablet caused 87 reported adverse drug reactions, with 19 hospitalizations.
The April 28 recall action affects all batches of nutritional products produced since May 1, 2002; 219 products have been identified so far. TGA is working with companies that were using Pan Pharmaceuticals for contract manufacturing to identify additional products for recall, which could push the number 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 the actions, as the company did extensive business manufacturing for distribution in Asia, 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 produces some pharmaceutical and OTC products. Pan Pharmaceuticals has not issued a statement about the recall; however, a spokesman for the company told INSIDER it would pursue all possible appeal processes.