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Recall of Food Supplements, Fortodol and Miradin – 24.03.09

Country of Origin: USA
Product: Fortodol and Leppin Miradin food supplements
Batch Code: All

Background

Swedish laboratory tests have found that some of these supplements have been contaminated with nimesulide, which is a medicine whose use has been suspended in Ireland because it was linked to severe liver-related illnesses. It has not been determined yet which batches contain nimesulide. These supplements are used as an anti-inflammatory and pain killer.

Both Sweden and Norway have reported cases of severe liver damage resulting in the death in a number of individuals in association with the use of the above products. The use of Nimesulide was suspended in Ireland in 2007 following similar reports.

To date the FSAI has identified only one online site offering Fortodol for sale to the Irish public, although they are aware of distribution in Northern Ireland and the U.K. To date the Irish Medicines Board or the FSAI have not identified any other distribution channels within the Republic of Ireland.

Nature of danger
There have been reports from other countries of acute liver failure and death linked to these contaminated products.

Action
Wholesalers, retailers
Please remove the implicated products from sale, display a point of sale notice to recall items from customers. Please inform rapidalert@fsai.ie of supply route.
Consumers
It is advising individuals who have any of the above products in their possession not to consume them. Any one who has been taking these products and feels unwell should consult with their GP.

Further details can be found on the FSAI website www.fsai.ie