DrugBuyers.Com: Australia hit by medicines recall

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Australia hit by medicines recall
Wednesday, April 30, 2003 Posted: 0018 GMT ( 8:18 AM HKT)

A Sydney pharmacist removes Pan products from her shelves

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SYDNEY, Australia (AP) -- Australia has ordered the recall of 219 products by Pan Pharmaceuticals and suspended its license after a series of safety and quality breaches.

Pan Pharmaceuticals' license was suspended for six months Monday. It represents 70 percent of the Australian non-prescription medicine market and exports to dozens of countries.

It also makes some over-the-counter medicines including paracetamol, codeine and antihistamines. A government agency has warned that thousands more products could possibly be recalled in the coming days.

Australia's Therapeutic Goods Administration suspended Pan's license following evidence of substitution of some ingredients, manipulation of test results and substandard manufacturing processes, according to Dr. John McEwen, the administration's principal medical adviser.

McEwen cited five instances where Pan released products containing raw materials that had not been tested for their safety and four cases where laboratory test results were manipulated to meet specifications.

Pan first came to the government's attention over its travel sickness tablet Travacalm, which was recalled in January. Faulty batches of the tablets resulted in at least 87 adverse reactions and 19 hospitalizations.

"Some people were very, very ill, they tried to jump out of planes, off ships and things like that because of the hallucinatory effect," Australia's federal parliamentary Health Secretary Trish Worth said.

Pan chief executive Jim Selim said Tuesday the company was working to comply with the agency's regulations.

"There will be immediate changes at Pan aimed at ensuring the review process will be undertaken without any bias," Selim said in a statement.

The Australian government ordered advertisements in newspapers Tuesday and Wednesday listing the recalled products.

Australian Prime Minister John Howard urged Australians not to panic and said the Therapeutic Goods Administration was justified in suspending Pan's license.

'Don't panic'
"It's also very important that people don't panic," Howard told Melbourne radio station 3AW Tuesday.

"On the evidence available the agency had no alternative other than to do what it's done, and we will continue to throw the book at anybody who doesn't match up to the standards that have been set," Howard said.

New Zealand's Food Safety Authority also told Pan to withdraw products it is selling there, although the authority said it was not sure which products would be affected.

Australian drug and herbal medicine companies Tuesday scrambled to distance themselves from the scandal with at least 10 companies declaring that none of their products are manufactured by Pan.

"All Roche brands are manufactured to the highest ethical standards for the health and safety of the public," Roche said in a statement.

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