Following an earlier FSA public warning about the products, FSA said 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 products have been linked to numerous liver damage-related adverse events in Scandinavia , including two deaths from liver failure.
“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,” FSA said, noting it was investigating whether the product could have been imported from other sources.
The FSA said no adverse events had been recorded in the UK but the importers had initiated the recall as a precautionary measure.
“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.”
The products in question are made by a Californian company called Donsbach, which typically exports the products to Sweden before they are shipped throughout Europe.
One of the Swedish cases involved a fatal liver failure which is under investigation by the Swedish Medical Products Agency. The Norwegian Medical Products Agency is conducting investigations of its own.
A similar scare in Hungary was given the all-clear by the regulator there after investigations revealed a lack of nimesulide at hazardous levels.