Recall of food supplements Miradin and Fortodol due to presence of unauthorised substance (nimesulide)

Wednesday 25 March 2009

Food Alert: for Action

Lepicol Ltd and Natural Health Products have recalled from sale all batch and date codes of food supplements labelled 'Miradin' (in UK mainland) and 'Fortodol' (in Northern Ireland) due to sporadic contamination with a banned drug nimesulide.

The affected product was exported by Hela Pharma in Sweden, imported into the UK mainland by Lepicol Ltd and in Northern Ireland by Natural Health Products. Both companies then distributed the product mainly to health food shops and pharmacies in England, Wales, Scotland and Northern Ireland. The Agency is investigating whether this product could have been imported via other routes.

Miradin/Fortodol is marketed as a food supplement that claims to be a natural anti-inflammatory pain killer for conditions such as arthritis and migraines. Reports of serious liver injury linked to these contaminated products have been received from Sweden and Norway. Therefore, this product may pose a serious risk to human health.

There have been no reports of illness linked with these products in the UK. As a precautionary measure, however, the two main UK importers have initiated a product recall. In addition, they have supplied all customers with point of sale notices to be displayed in their retail outlets advising consumers of the product recall.

For more background information please see FSA web story at the links below.

Product recalled

In Northern Ireland:
Fortodol 40 capsules and 100 capsules
All date codes
All batches

In UK mainland:
Miradin 40 capsules and 100 capsules
All date codes
All batches

Copies of point-of-sale notices issued by Lepicol Ltd and Natural Health Products are attached below.

Helpline numbers have been provided by the UK importers:

• Lepicol Ltd: 0500 127 249 (free phone)
• Natural Health Products: 028 9070 3100

Images of the products can be found below.

Actions to be taken by Local Authorities

If the product imported by Lepicol Ltd and Natural Health Products is found to be on premises officers should:

• Remove the product from sale using powers under the Food Safety Act 1990. The product should be returned to their supplier.
• Encourage food businesses operators to display point of sale notices explaining the reasons for the recall to consumers.

Other local authorities are requested to look for the above products during routine visits to food health stores and pharmacies in their area and report any findings to the Agency.

It is essential that all Non Unitary Authorities liaise at county level to ensure that they co-ordinate their actions.