People have been buying condoms from pharmacies across the State for the past 10 months completely unaware the products were fakes sold under the Durex brand name and they may have had holes in them.
The revelation was made yesterday by the Irish Medicines Board (IMB) which said it had written to pharmacies warning them about the counterfeit products and ordering them to quarantine them.
The discovery followed complaints to Durex by a number of Irish customers in recent weeks that condoms they bought had burst.
The company became suspicious that the condoms were counterfeit products and a week ago it alerted the IMB.
The IMB began an investigation and found the condoms, marketed in almost identical packets to Durex condoms, were only being sold through chemists who would have bought them from wholesalers. They are believed to have originated in China.
Two counterfeit batches have been identified. They were marketed as Durex Extra Safe and Durex Fetherlite condoms. Only 12-packs are affected.
The IMB said it had already seized a large proportion of the counterfeit stocks but it estimates around 40,000 boxes containing some 480,000 condoms, have already been sold to consumers.
Ann O'Connor, medical devices director with the IMB, said the fakes would have been sold between May 2004 and this month. Tests on the condoms showed they were unsafe and did not meet the stringent European standard for condoms, she said.
She acknowledged that people might now be concerned about unwanted pregnancies or sexually transmitted diseases.
"All we can advise is that if patients are concerned they should attend their GP and discuss the matter with them," she said.
She added that from the IMB's investigations to date the fake condoms had been supplied by the wholesale sector to pharmacies only.
The IMB has advised consumers to check to see if they may have the condoms in their possession. People should check the outer packet and the condom foil for the batch details. The two counterfeit batches identified carry the following details: Durex Extra Safe 12-Pack Batch number: 20602503 Expiry Date: 2007/11 and Durex Fetherlite 12 Pack Batch number: VR3073 U or C or E or expiry date: 2008/02. Consumers are advised to return any affected product to their local pharmacy.
Dr Karl Hilton, president of the Irish Pharmaceutical Union, said he was as surprised as anybody else by the revelation. He said pharmacists had been buying condoms from suppliers whose bona fides they trusted for many years.
"If we do find that counterfeit condoms have been sold through pharmacies it is the responsibility of the IMB to make sure there are clear distribution channels for condoms in the same way as there are tight controls in the supply of medicines," he said.
"Ultimately the safety of medicines and medical products is the IMB's responsibility," he said.
He advised pharmacies to check their stocks and if they had any of the batches mentioned to get them off their shelves.