- Print Friendly - Help

Pan Pharmaceuticals - Questions and Answers

These Q&As have been adapted for the New Zealand situation from the information on the TGA website. Further information will be added as it comes to hand.

• What is the issue?
• Why has this action been taken?
• What products have been recalled in New Zealand?
• How can I find out if my supplements are affected?
• Are there products other than Dietary Supplements affected?
• What do I do if I have concerns about my health?
• If I have any of these products, what do I do?
• What do batch and expiry details look like and where do I find these?
• Who is Pan Pharmaceuticals Limited?
• Where can I obtain further information?

What is the issue?

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

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

Some of these products have however, been sold, or were for sale, in New Zealand. The Minister for Food Safety, Annette King, has therefore recalled them here as well. So far four recalls have been ordered in New Zealand. The lists of recalled products have been published in some daily newspapers and appear on this website.

Why has this action been taken?

The New Zealand Food Safety Authority has a responsibility to protect the health and safety of all New Zealanders and is obligated to take action where there is a concern in relation to the quality, safety or effectiveness of food and food related products.

This action by the NZFSA follows investigation of Pan Pharmaceuticals Limited by the TGA 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. In Australia there have been 87 adverse reactions to Travacalm reported to the TGA, 19 of which were serious enough to require treatment of patients in hospitals. A consumer level recall of two Travacalm products (Travacalm Original and Travacalm HO), both made by Pan Pharmaceuticals Limited, was undertaken in Australia 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 six 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 Minister for Food Safety has taken the decision to recall all products in New Zealand which have been identified by TGA in Australia as products of concern.

What products have been recalled in New Zealand?

A full list of recalled dietary supplements, which includes dietary supplements recalled in Australia but not necessarily available here, is available on the NZFSA web site. The list contains information on the name of the product, the supplier, the batch number, the expiry date and, where applicable, an Aust L or R number.

This list and the website will be updated as further information becomes available. Consumers will also be alerted through further newspaper advertisements if there are any further products to be recalled. Products in New Zealand are unlikely to be labelled as manufactured by Pan Pharmaceuticals Ltd. The name of the manufacturer (if this is different from the name of the sponsor or supplier of the dietary supplement) is not usually included on the label.

How can I find out if my supplements are affected?

You can find out whether the product(s) you have been using have been recalled either through this website or by phoning our helpline on 0800 693 721. You will be able to do an online search of any of product you have if it has been recalled. If the product has not been recalled it will not appear on the list. Not all dietary supplements are implicated in the recall of Pan Pharmaceuticals Ltds products.

Are there products other than Dietary Supplements affected?

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

Only three medicines for human use that are registered and distributed in New Zealand have been identified. The medicines are : No Doz, No Doz Plus and Mintec. These products have already been recalled and the company responsible for distribution has placed advertisements in newspapers announcing this.

MedSafe, which is part of the Ministry of Health, is responsible for the regulation of human medicines in New Zealand. MedSafe is managing the recall of medicines manufactured by Pan Pharmaceutical Limited. Information from MedSafe is available on (04) 496 2000 (ask to speak to the MedSafe Compliance Team).

What do I do if I have concerns about my health?

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

If I have any of these products, what do I do?

You should not use any products that have been recalled. These should be safely disposed of by returning them to the place of purchase.

The Consumer Guarantees Act (CGA) provides protection for consumers who purchase goods that are not "fit for purpose". This is a matter between the seller and the purchaser. Buyers who return goods that are not "fit for purpose" may either be given their money back or provided with a replacement of a similar value and type.

The Ministry of Consumer Affairs administers the CGA. Enquiries regarding refunds can be made to: Ministry of Consumer Affairs, PO Box 1473, Wellington, New Zealand Ph (04) 474 2750 http://www.consumer-ministry.govt.nz

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

Batch numbers and expiry dates must be shown on the labels of products. 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').

Who is Pan Pharmaceuticals Limited?

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 medicines and dietary supplement products in Australia and many of these are available in New Zealand. Of these 668 products have so far been recalled in Australia.

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

Where can I obtain further information?

Further information can be found on the NZFSA web-site or by phoning the toll-free Helpline on 0800 693721 (hours 8 am - 8 pm 7 days per week).