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Pan products were ‘harmful’: TGA

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PAN Pharmaceutical products were so badly manufactured, consumers could have died, been seriously injured or become ill, the Therapeutic Goods Administration revealed yesterday.

PAN Pharmaceutical products were so badly manufactured, consumers could have died, been seriously injured or become ill, the Therapeutic Goods Administration revealed yesterday.The TGA declaration comes after former head of Pan Pharmaceuticals Jim Selim last night called for a judicial inquiry into the pharmaceutical watchdog on the ABC’s Australian Story program. Pan Pharmaceuticals had its licence suspended in April because of serious quality and safety breaches identified by the TGA.A total of 1624 Pan products was recalled in Australia’s biggest recall of medicines, and Pan was placed in voluntary administration in May.The TGA will revisit Pan Pharmaceuticals for a three-day audit tomorrow to see whether it is compliant, particularly in manufacturing soft-gel supplements.Mr Selim also called for the release of TGA evidence to justify the recall and the withdrawal of the Pan licence, saying the TGA should be answerable to the public. “If it has damaged and caused pain for the public and Pan and the customers of Pan and the shareholders of Pan, then they have to apologise to them and compensate them,” Mr Selim said.The federal Government yesterday rejected the call for an inquiry into the TGA. Parliamentary secretary for the Minister for Health and Ageing Trish Worth yesterday said she was satisfied with the investigation conducted by the TGA. “I suppose it’s predictable that Mr Selim would go on the offensive since he’s found himself in such hot water and has let so many people down, and (has been) endangering, in fact, the Australian public,” Ms Worth said on ABC Radio yesterday. Mr Selim told the ABC he was considering legal action against the TGA. The TGA said yesterday that it did not test all of the recalled Pan products because manufacturing processes were considered so poor.The TGA said there was such “widespread endemic deplorable practices by the company, particularly in basic hygiene such as cleaning equipment between batches that any product ingredient was considered a potential contaminant for any other product subsequently manufactured”.”In their assessment of the risks posed by audit evidence of Pan Pharmaceuticals the expert committee found that the multiple failures of good manufacturing practice identified in the auditors’ report created risks of death, serious illness, and serious injury,” the TGA said. (Source: The Australian, By Patricia Karvelas and Jennifer Sexton, August 26, 2003)

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Dates

Posted On: 26 August, 2003
Modified On: 5 December, 2013


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