Product recall prompted by failure of dissolution test
24 Sep 2010
The Department of Health (DH) has ordered a 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.
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 active ingredient dissolved in a specific time after consumption.
According to the specification of the product, at least 75% of the labelled active ingredient should be dissolved in 15 minutes. However, analysis showed that less than 40% of the active ingredient was dissolved. The failure could explain that the product may not have the expected effectiveness.
The product is manufactured by Christo Pharmaceuticals (Guangzhou) Company Limited in the Mainland and contains cimetidine, which is used for treating gastric and duodenal ulcers. The product is an over the counter product and could be sold in pharmacies and medicine shops without supervision of a pharmacist.
The product is 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 (box of 12 tablets) and 13 bottles (bottle of 1000 tablets) of the product had been supplied to medical doctors, local pharmacies and some medicine shops. It is expected that only less than 20% of the supplied product are 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 the batch of the product to their clients. DH will closely monitor the recall.
"People who have used the product should consult healthcare professionals if in doubt," he said.