Pan Pharmaceuticals Limited: Regulatory action & product recall information

28 April 2003

Regulatory action and product recall information

The Therapeutic Goods Administration (TGA) has 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.

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.

In addition, a further, larger recall of products manufactured by Pan Pharmaceuticals Limited under contract for other sponsors is underway. The TGA has been working with the sponsors of these products to identify those for recall. Lists of these products have been published in the newspapers and details are also available on this website.

A single batch of the antidepressant medicine, Allegron 25 mg is being recalled as part of the recall of medicines manufactured by Pan Pharmaceutical Limited. The recall applies only to this prescription medicine, and only to 178 packs of a single batch of Allegron that was released to pharmacists in parts of NSW and Queensland. Details of the batch number and action required by patients who have had medicines prescribed from this batch are available at Media release: Allegron 25MG subject to PAN Pharmaceutical recall.

No safety problems have been identified with any other prescription medicines available in Australia. Australians may continue to take their prescription medicines.

Recall information on this website will be updated regularly.

Media releases

Contact details

  • For media enquiries, please contact Kay McNiece on 0412 132 585
  • For enquiries by sponsors of products, please contact the Non-Prescription Medicines Branch Call Centre on 02 6232 8805
  • Pan Pharmaceuticals Ltd Recall hotline for consumers - 1800 190 007

Information for consumers & retailers

Information for industry

How to access a pdf document

Guidance for sponsors who wish to voluntarily recall products that have been manufactured by Pan Pharmaceuticals limited

The contents of this package summarises for sponsors their responsibilities and role in undertaking a recall in accordance with the Uniform Recall Procedure for Therapeutic Goods (URPTG). It also provides sponsors with a range of streamlined procedures to assist in the smooth running of the recall.

Pan Pharmaceuticals: Sponsor recall package (pdf,75kb)

Product questionnaire

Sponsors were asked to complete this Product Questionnaire for each and every product on the Australian Register of Therapeutic Goods (ARTG) where they are the nominated sponsor and Pan Pharmaceuticals is a nominated manufacturer.

Pan Pharmaceuticals: Product questionnaire - product information required by the TGA (pdf,84kb)

Information for overseas regulatory agencies

How to access a pdf document

The following are lists of approximately 1650 'export-only' medicines which have been manufactured AND sponsored by Pan Pharmaceuticals Ltd. All of the following medicines have been cancelled from the Australian Register of Therapeutic Goods, with effect from 28 April 2003.

Refunds

Food

Veterinary products