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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7314 p277
28 August 2004

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Pharmacy dispenses counterfeit Cialis to patient

Counterfeit Cialis (tadalafil) has been identified in the UK after being dispensed by a pharmacy for a patient. The product is believed to have been obtained through legitimate supply channels. Two batches of the product, not manufactured by Lilly ICOS UK Ltd, have been recalled (see p283). The recall is to be carried out down to the level of individual patients who might have received the product.

The fake product was discovered after a patient reported to Lilly that 20mg tablets he had tried to break in half were crumbly. The company tested the tablets, decided that they were probably counterfeit and reported the discovery to the Medicines and Healthcare products Regulatory Agency.

Subsequent investigations led to the identification of two batches in circulation whose batch numbers did not match any used by Lilly for genuine product. The two batch numbers are A031410 (packs of four) and A041210 (unknown pack size).

A Lilly spokesman said that any patients who had received fake product would have it replaced by the company free of charge. Pharmacists who are aware of any counterfeit product can contact Lilly customer services on 0800 0853847. He added that no information could be given about where in the UK the fake product had been discovered.

A recall notice issued by the MHRA says that initial tests on the bogus tablets do not indicate that there is any immediate risk to patients.

Instances of counterfeit medicines reaching patients through legitimate supply channels in the UK are rare. The DoH said only last month that there had been no definite evidence of counterfeit pharmaceuticals reaching the public via the legitimate supply chain since counterfeit Zantac was discovered in 1994 (PJ, 3 July, p6).

Tony Moffat, chief scientist at the Royal Pharmaceutical Society, added that there had been no reported case of counterfeit medicines in the legitimate chain in the past eight years.

Not everyone agrees that counterfeit medicines are not a problem in the UK. At the end of 2000, the Centre for Economic Business Research said that 6 per cent of pharmaceuticals in the UK were probably fake (PJ, 23/30 December 2000, p905).
Correction
The batch numbers of counterfeit Cialis (tadalafil) tablets that have been recalled are A031410 and A041410, not as stated. Pharmacists should contact their wholesalers directly for exchange, not Lilly ICOS.

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