MHRA RECALLS COUNTERFEIT CIALIS TABLETS

24 Aug 2004 10:45 AM

The Medicines and Healthcare products Regulatory Agency (MHRA) is recalling two lots of counterfeit (fake) Cialis 20 mg tablets following the discovery of counterfeits of the drug in the legitimate supply chain.

Cialis is used to treat erectile dysfunction and is manufactured and distributed by Eli Lily Ltd. Initial tests of the counterfeit product show that the counterfeits do not pose an immediate risk to patients. The lot numbers affected are A031410 and A041410 (these numbers can be found at the end of the carton and on the blister strip inside the carton). Any patient in possession of either of the above lot numbers should return the material from where it was purchased.

MHRA Chief Executive, Professor Kent Woods said:

"Patients who are in possession of this counterfeit drug should return it immediately. Whilst initial tests show that the product does not pose an immediate risk to patients, the quality of this product can not be guaranteed. If patients think that they have taken the product and are concerned about any side effects they should consult their doctor".

No lots manufactured and distributed by Lilly ICOS Ltd are impacted by this recall, and there is no concern with the genuine Lilly ICOS product.

Patients who are concerned about the recall can also contact Eli Lilly on the following free phone number: 0800 085 3847.

Notes to Editors:

1. This is the first such incident of a counterfeit product being discovered in the legitimate UK supply chain since the case involving AZANTAC (ranitidine) tablets in 1994.

2. Cialis (tadalafil) is used to treat erectile dysfunction and is a centrally authorised product (by EMA European Medicines Agency) Eli Lilly product. The licence holder is Eli Lilly and Co Ltd.

3. The Medicines and Healthcare products Regulatory Agency (MHRA) investigates all allegations of counterfeit medicines in the UK, the vast majority of which are not associated with the tightly regulated legitimate supply chain. Action in the form of legal proceedings is taken when appropriate.

4. Counterfeit medicines is a global problem, therefore the MHRA continues to liaise closely with international Regulatory partners and the pharmaceutical industry to ensure that the tackling of counterfeiting medicines remains a priority activity.