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Posted April 30, 2003

Massive Recall by Australian Supplement Maker

On April 28, 2003, Australia's Therapeutic Goods Administration (TGA) suspended the licence held by Pan Pharmaceuticals Limited of Sydney to manufacture medicines, for a period of six months with effect 28 April 2003, because of serious concerns about the quality and safety of products manufactured by the company.

The suspension follows audits of the company's manufacturing premises, 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. The licence has been suspended in order to urgently address the safety and quality concerns posed by the multiple manufacturing breaches. Where the quality of a medicine cannot be certain, neither can the safety or effectiveness of that medicine.

Due to the serious and widespread nature of the manufacturing problems identified and following expert advice regarding potential risks, the TGA has taken the decision to recall all batches of medicines manufactured by Pan Pharmaceuticals Ltd since 1 May 2002 and that are being supplied on the Australian market.

So far, 219 products manufactured and supplied in Australia by Pan Pharmaceuticals Limited have been identified for immediate recall. These products have been cancelled from the Australian Register of Therapeutic Goods for quality and safety reasons. The company has also had its approval to supply its range of export products (approximately 1650) cancelled.

It is expected that a further, larger recall of products manufactured by Pan Pharmaceuticals Limited under contract for other sponsors will occur within days. The TGA will be working with the sponsors of these products to identify those for recall.

Click on the link below for more information including listings of affected products sold in Australia and exported internationally.