You are here

Pan Pharmaceuticals: Questions & answers for consumers & retailers

National medicines regulator suspends drug company's manufacturing licence

23 December 2003

Questions & answers for consumers

Q. Who are Pan Pharmaceuticals Limited?

A. Pan Pharmaceuticals Limited 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 (for example, paracetamol & codeine) and cold and flu preparations (for example, antihistamine & pseudoephedrine).

The company manufactures several thousand widely available medicines in Australia and additionally, many of the products they manufacture are exported to overseas countries.

A range of products manufactured by Pan Pharmaceuticals Limited is also supplied to other companies which market the products under their own brands.

Q. What action has been taken?

A. The licence held by Pan Pharmaceuticals Limited to manufacture medicines has been suspended for a period of 6 months because of serious concerns about the quality of products manufactured by the company. Where the quality of a medicine cannot be certain, neither can the safety or effectiveness of that medicine.

For this reason, the Therapeutic Goods Administration (TGA), Australia's national regulator for medicines and other therapeutic goods, is requiring the recall of all product identified as having been manufactured by Pan Pharmaceuticals Limited since 1 May 2002 and that are being supplied on the Australian market.

Q. Why has this action been taken?

A. The Therapeutic Goods Administration (TGA) has a responsibility to protect the health and safety of all Australians and, as Australia's national regulator for medicines, is obligated to take action where there is a concern in relation to the quality, safety or effectiveness of medicines. Manufacturers of medicines must comply with strict manufacturing standards, so consumers can be confident of the quality and safety of the medicines they take.

This action by the TGA follows investigation of Pan Pharmaceuticals Limited after serious and life threatening adverse reactions were experienced by people who took an over-the-counter travel sickness tablet (Travacalm Original) manufactured by Pan Pharmaceuticals Limited. There have been 87 adverse drug reactions to Travacalm reported to the TGA, 19 of which were serious enough to require treatment of patients at hospitals. A consumer level recall of two Travacalm products (Travacalm Original and Travacalm HO), both made by Pan Pharmaceuticals Limited, was undertaken in January 2003 as a result.

Inspections of Pan Pharmaceutical Limited manufacturing premises have since found evidence of widespread and serious deficiencies in the company's manufacturing and quality control procedures. The company's manufacturing licence has therefore been suspended for 6 months to urgently address the quality and safety concerns posed by the manufacturing breaches.

Due to the serious and widespread nature of the problems identified in manufacturing, 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.

Q. Why did it take so long for the TGA to respond to the breaches of manufacturing practices by Pan Pharmaceuticals Ltd?

A. The TGA became aware of potential manufacturing problems at Pan Pharmaceuticals Ltd in mid-January this year when serious adverse events associated with the travel sickness tablets Travacalm (manufactured by Pan Pharmaceuticals Ltd) were reported. The TGA took immediate action to remove the Travacalm products from the market and to suspend the ability of Pan Pharmaceuticals Ltd to continue to make products of that type.

The TGA then commenced further audits of the company to investigate whether the problems that existed with the manufacturing of Travacalm could be problems of a more general nature with the company's manufacturing processes. These audits revealed widespread additional problems with the company's manufacturing procedures including systematic and deliberate manipulation of quality control test data and other serious breaches of good manufacturing practice (GMP).

An unannounced audit of all of Pan Pharmaceuticals Ltd's operations was therefore planned to take place in the week of 24 February 2003. Due to objections by the company, TGA officers were only able to examine limited records on that occasion and the audit was limited to two days, 24 and 25 February. However, they took away with them a range of data which after extensive analysis, highlighted areas of concern to be targeted for careful investigation in a further audit. Another unannounced audit was completed over the period 7 - 14 April 2003. Thereafter, the auditors prepared a detailed report of the audit and its findings. By the very nature of the extent and systemic reach of the problems identified during the audits, preparation of the report required painstakingly attention to detail and was a time consuming process.

The audit report was considered by an Expert Advisory Group established to advise the TGA on the health and safety risks posed to consumers of products manufactured by Pan Pharmaceuticals Ltd.

The Expert Group met on 23 April 2003, and recommended to the TGA that the manufacturing breaches were of such consequence that it was considered that ongoing availability of Pan Pharmaceuticals Ltd's products represented very serious risks to the community. They advised that the risks would increase over time, and that they could be realised at any time. Following this advice, and other matters raised by the audit reports, the TGA moved to immediately suspend the manufacturing licence of Pan Pharmaceuticals Ltd and commence a recall of all products made by the company since 1 May 2002 (when the company's last satisfactory GMP audit had been completed).

The TGA is confident that the whole audit, evaluation and decision-making process has been completed within in a minimum timeframe necessary to enable a proper audit and a considered decision to be made. Elapsed time between the first unannounced audit and the TGA's final decision has been consumed by investigations, systematic and careful analysis of findings, the seeking of expert advice and finally, a proper consideration of relevant matters before a decision was made on 28 April 2003. Any less care leading up to a decision of this regulatory magnitude may not have been defensible.

Top of page

Q. What medicines are affected?

A. The medicines of most concern are those manufactured by Pan Pharmaceuticals Limited since 1 May 2002.

Not all medicines included on the Australian Register of Therapeutic Goods showing Pan Pharmaceuticals Limited as a possible manufacturer, have been manufactured by the company in this time period. Sometimes alternative manufacturers are nominated and used by sponsors to make their products.

The actual product range and number of batches that have been manufactured by Pan Pharmaceuticals Limited since 1 May 2002 is still being determined by the TGA, in co-operation with affected sponsors. However several thousand products may be involved.

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.

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

Q. Are medicines manufactured by Pan Pharmaceuticals Limited going to be recalled?

A. Products identified as having been manufactured by Pan Pharmaceuticals Limited since 1 May 2002 and that are being supplied on the Australian market will be recalled.

Details of the medicines recalled will be available on this website and will be notified in major metropolitan newspapers in each State and Territory.

Details of consumer level recalls will also appear on the Product Recalls Australia website.

Recalls will most often only relate to specific batches of product, and therefore you should take note of the batch and expiry date details on your medicines to see if they are included in the recall.

Q. How can I find out if my medicines are affected?

A. Go to Medicine Recall - Products manufactured by Pan Pharmaceuticals Limited and supplied by various sponsors and distributors advertised for consumer level recall.

The list of recalled products can be searched either by product name or AUST L/AUST R number (a 5 digit number prefixed by the letters AUST R or AUST L located on the font panel of the label, usually in a lower corner).

Details of recalled products will also be published in at least one major metropolitan newspaper in each State and Territory.

Details of consumer level recalls will also appear on the Product Recalls Australia website.

Recalls will most often only relate to specific batches of product, and therefore you should take note of the batch and expiry date details on your medicines and those given in the lists and advertisements.

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.

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

Q. How do I know if my medicine has been manufactured by Pan Pharmaceuticals Limited?

A. The name of the manufacturer (if this is different from the name of the sponsor or supplier of the medicine) is not usually included on the label.

You will need to check the lists of recalled products published on this website or in major metropolitan newspapers to see if your medicine is affected and being recalled.

While Pan Pharmaceuticals Limited manufactures a wide range of products, these are mostly complementary medicines such as herbal, vitamin, mineral and nutritional supplements, and some over-the-counter (OTC) medicines such as pain relievers and cold and flu preparations.

As many product names are similar, it is important that the AUST L or AUST R number, which can be located on the front panel of the label, is checked. It is also important that batch numbers are expiry dates are checked.

Q. Should I stop taking my medicines?

A. While it is important that you do not stop taking essential medicines, you should not take any medicines that have been recalled. These should be safely disposed of by returning them to a pharmacy, or the place of purchase.

If you feel unwell and you think it is because of your medicines, or you are otherwise concerned, you should contact your healthcare professional.

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.

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

Top of page

Q. If I have purchased any of these products, what do I do with them now?

A. You should not take any medicines that have been recalled and should safely dispose of any unused portions. These may be returned to your pharmacy for safe disposal, or their place of purchase.

Q. If I return my products to the place of purchase, will I get a refund?

A. This is a matter for the sponsor or supplier of the product and is not the subject of TGA legislation. You may wish to check with the sponsor of the medicine shown on the product label or the retail outlet from which the medicine was purchased.

Q. How do I dispose of unwanted medicines?

A. Any unwanted medicines or those past their expiry (use-by) date can be returned to your pharmacy for safe disposal.

Q. We have heard mention of 'export products' being affected by the TGA action against Pan Pharmaceuticals Limited. Is there any impact of this upon Australian consumers?

A. No, export products are listed on the Australian Register of Therapeutic Goods strictly on the basis they are for export only. The TGA is working with the affected sponsors to ensure overseas health authorities are being appropriately informed of the action being taken.

Some sponsors who supply their products in Australia also choose to export these same products. These are not 'export only' products and will be treated the same as other locally supplied products.

Q. What is the TGA?

A. The Therapeutic Goods Administration (TGA) is Australia's national regulator for medicines and other therapeutic goods. It is the part of the Commonwealth Department of Health and Ageing and through administering the Therapeutic Goods Act 1989 is responsible for ensuring the safety, quality and effectiveness of therapeutic goods available in Australia.

Q. What is the Australian Register of Therapeutic Goods?

A. The Australian Register of Therapeutic Goods (ARTG) is a database held by the TGA containing information on medicines and other therapeutic goods approved for supply in Australia.

Q. What is an AUST L or AUST R number?

A. AUST L and AUST R numbers are identifying numbers given to individual medicines when they are included on the Australian Register of Therapeutic Goods. Manufacturers are required to show these numbers on the front panel of the label of medicines, and they are usually located in a lower corner. These are 5 digit numbers prefixed by the letters AUST R or AUST L. As many product names are similar, it is important that this number is checked.

Q. What do batch and expiry details look like and where do I find these?

A. Batch numbers and expiry dates must be shown on the labels of medicines. They are often located on the back panel of the label on bottles or end flaps on boxes. These numbers allow the tracing of production batches through all stages of manufacture.

Batch numbers can be a combination of letters and/or numbers, and are prefixed with letters or a symbol which clearly indicate that the number is the batch number (for example, 'Batch No.', 'B', 'Lot Number', 'Lot No.' or words or symbols to this effect). Expiry dates are the month and year after which the goods should not be used, and have a prefix which indicates that the following information is the expiry date (for example, 'Expiry', 'Expires', 'Exp. Date', 'Use before').

Q. Where can I obtain further information?

A. Further information can be found on this website: Pan Pharmaceuticals Limited - regulatory action and product recall information.

Q. What is the frequency of GMP audits of manufacturers?

A. TGA's GMP audit program is based on an overall average re-audit frequency of 24 months. Risk management principles are used to determine the actual re-audit frequency for each manufacturer. This is based on product risk category and GMP compliance history and as a result the actual re-audit frequency may vary from 12 to 36 months. If necessary the TGA can also conduct GMP audits at any time to follow up an event that may reflect on GMP compliance, e.g. product recall.

The re-audit frequency adopted by the TGA is consistent with international best practice and is comparable with that adopted by equivalent regulators such as Canada, European countries including the UK, and Singapore.

Questions & answers for retailers

Q. How do I know what products to take off the shelves?

A. The sponsors of products being recalled will contact retail outlets with instructions, but a list of the recalled products is available on this website.

Top of page