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Press Release

Recall of unregistered Povidone-iodine Prep Pad (with photo)

7 May 2009

Department of Health today (May 7) has instructed Luen Cheong Hong Ltd (LCH), a licensed drug wholesaler, to recall Povidone-iodine Prep Pad as the product was found to be a pharmaceutical product without registration in Hong Kong.

Under the Pharmacy and Poisons Ordinance, antiseptic and disinfectant pads containing povidone-iodine are pharmaceutical products and must be registered before sale.

Investigation by DH found that the registration of the product had been expired in October 2008 and had not been renewed due to insufficient information to support the expiry date.

Povidone-iodine Prep Pad was manufactured in USA and was once registered in Hong Kong from 1998 to 2008. It was sold in 100 pads per box pack size.

Initial investigation by DH revealed that LCH had been selling the product after the expiry of the product registration.

Based on the information available, there is no immediate safety concern with the product. However, doctors and pharmacists are reminded to stop using or supplying it to their clients as the product is an unregistered pharmaceutical product in Hong Kong.

Consumers should stop using the product and seek medical advice from their doctor, if necessary.

The spokesman said the pharmaceutical product was supplied to Hong Kong Red Cross, private hospitals and pharmacies.

DH has instructed the company to recall the product immediately.

Doctors and pharmacists were informed of the recall.

LCH has set up a hotline 2575 6079 for enquiries.

DH will closely monitor the recall.

The spokesman said that the sale of unregistered pharmaceutical product was an offence under the Pharmacy and Poison Ordinance. Upon conviction, the maximum penalty is a fine of HK$100,000 and 2 years' imprisonment.

07 May 2009