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 Tuesday, April 29, 2003

 

BIGGEST MEDICAL RECALL IN AUSTRALIAN HISTORY....LICENCE OF PAN PHARMACEUTICAL LTD SUSPENDED BY MEDICAL WATCHDOG



Major news headline today on Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements, Pan Pharmaceuticals was ordered to withdraw IMMEDIATELY 219 of its products and had its licence suspended for 6 months by Australia's medicine watchdog, the Therapeutic Goods Administration (TGA) for grave safety and quality breaches.

Pan holds 70 per cent of the Australian complementary medicine market and exports to dozens of countries. Pan is Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements. It also makes some over-the-counter medicines including paracetamol, codeine, antihistamines and pseudoephedrine.

Pan sold its products in generic form which are then rebranded under different brand names. These would be added to the list by TGA as they are being identified.

The TGA warned the number of products recalled could blow out to several thousand in coming days.

The charges against the pharmaceutical company by TGA include:

  • evidence of substitution of ingredients, manipulation of test results and substandard manufacturing processes.

  • released products containing materials that had not been tested for their safety

  • four cases where laboratory test results were manipulated to meet regulatory specifications.

  • four recent examples of test results of an export vitamin product being fabricated.

  • on several occasions beef cartilage had been substituted for shark cartilage in a shark cartilage preparation.

  • a product may not be true to label. It may have a herb in it that has not been appropriately tested and may have a contaminant in it that could cause a serious illness ... or potentially fatal allergic reaction.

TGA principal medical officer, John McEwan, told an Australian news network that people should to be patient for the next few days until complete lists were published in newspapers and in the TGA website.

Pan Pharmaceuticals yesterday failed to call for a trading halt in its shares on the Australian Stock Exchange (ASX) as soon as it learnt its licence had been suspended.Shares in the company were still being traded while health authorities held a press conference to list a string of serious safety and quality breaches. ASX officials are angry.

Legal action by affected parties, including investors, commercial partners and consumers will be a certainty in the near future.

At the center of the debacle are its founder, managing director and biggest shareholder Jim Selim, and chairman Ross Brown, a governor of the Pharmacy Practice Foundation of the University of Sydney.

The products on recall are listed here in alphabetical order and by Australian reference numbers.

You can download the list of the products from here



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