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The Department of Health (DH) has ordered the recall of one batch of Cimedine Tablet 400mg (batch number S081121, registration number HK-40956) from the market after samples of the product failed the dissolution test.
The DH conducted an investigation and tested samples of the product after receiving a complaint about its effectiveness. Today (September 24), one batch of the product was found to have failed the dissolution test. The test was to analyse the percentage of the active ingredient that dissolved during a specific time after consumption.
According to the specification of the product, at least 75% of the labelled active ingredient should dissolve in 15 minutes. However, analysis showed that less than 40% of the active ingredient had dissolved. The failure could explain why the product may not have the expected effectiveness.
The product is manufactured by Christo Pharmaceuticals (Guangzhou) Company Limited on the Mainland and contains cimetidine, which is used for treating gastric and duodenal ulcers. The product is an over the counter product and can be sold in pharmacies and medicine shops without the supervision of a pharmacist.
The product was imported and distributed by Christo Pharmaceuticals Ltd (Christo Pharm), a licensed drug wholesaler, in January 2009. According to Christo Pharm, a total of 1,526 boxes (12 tablets per box) and 13 bottles (1,000 tablets per bottle) of the product had been supplied to medical doctors, local pharmacies and some medicine shops. It is expected that less than 20% of the supplied product is left on the market.
Christo Pharm has set up a hotline, 2498 6479, for public enquiries.
The spokesman urged healthcare professionals and retailers to stop supplying that batch of the product to their clients. The DH will closely monitor the recall.
"People who have used the product should consult healthcare professionals if in doubt," he said.
Ends/Friday, September 24, 2010
Issued at HKT 19:30
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