The Therapeutic Goods Administration (TGA) has suspended the licence held by Pan Pharmaceuticals Limited of Sydney to manufacture medicines after TGA inspectors found a series of serious safety and quality breaches by the company. These included substitution of ingredients, manipulation of test results and substandard manufacturing processes.

In addition the regulator ordered an urgent recall of 219 products, which Pan Pharmaceuticals manufactures and supplies in Australia on April 28, 2003. On Wednesday, another 449 Pan products were added to the recall list and on Thursday a further 701 products were identified for recall. This brings the total number of the company's products identified for recall to 1369.

The recall of these products is being undertaken because of serious concerns about the quality of products manufactured by Pan Pharmaceuticals since that date. Pan Pharmaceuticals is Australia's largest contract manufacturer of complementary medicines such as herbal, vitamin, mineral and nutritional supplements. They also manufacture some over-the-counter (OTC) medicines including pain relievers (paracetamol & codeine) and cold and flu preparations (antihistamine & pseudoephedrine).

Other companies also use Pan Pharmaceuticals' facilities to manufacture their own branded products and the TGA will be working with these companies to identify, which other products should be subject to recall.

Malaysian health authorities on Wednesday ordered products manufactured by Pan Pharmaceuticals to be stripped from store shelves because of quality control concerns. New Zealand food authorities are also recalling all Pan Pharmaceutical products. The NZ Food Safety Authority (NZFSA) said it was still trying to determine what products made by Pan were on the market.

This is not the first action taken against Pan Pharmaceuticals. In January this year an anti-travel sickness tablet, Travacalm manufactured by Pan Pharmaceuticals for another company, was the subject of a consumer recall. Faulty batches of the tablets were responsible for 19 people being hospitalised and 68 others experiencing potentially life threatening adverse reactions to this over-the-counter medicine.

Subsequent laboratory testing by the TGA of some of the tablets revealed that one of the active ingredients - hyoscine hydrobromide - varied in content from 0 - 700% of the listed dose. The company's manufacturing licence was immediately restricted to prevent the manufacture of Travacalm tablets and similar microdose products. The TGA undertook further audits of the company, which also revealed serious deficiencies in the company's manufacturing and quality control procedures, including systematic and deliberate manipulation of quality control test data.