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Recall of Fusen E.M. Cap 100mg (with photos)
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     The Department of Health (DH) today (December 10) endorsed the decision of a licensed drug wholesaler, Hitpharm Pharmaceutical Co Ltd, to recall all batches of Fusen E.M. Cap 100mg (registration no. HK-49463) from the market because of quality issues.

     During the DH's market surveillance programme, samples from one batch (batch no. 012015) of Fusen E.M. Cap 100mg were collected from the market for testing by the Government Laboratory. Today the Government Laboratory confirmed that the active ingredient content of the product was found to be less than the label's claim (about 80 per cent). The samples have also failed the dissolution test. As a precautionary measure, Hitpharm decided to recall all batches of the product from the market.

     The DH's investigation is continuing.

     According to Hitpharm, Fusen E.M. Cap 100mg is manufactured by Chin Teng Pharmaceutical Industrial Co Ltd in Taiwan. The product was distributed to pharmacies, medicine companies and registered medical practitioners in Hong Kong as well as exported to Macau.

     Fusen E.M. Cap 100mg is an over-the-counter medicine containing aspirin, which is an antithrombotic indicated for the prevention of embolism.

     A DH spokesman said, "The quality defect can affect the effectiveness of the product. Thus, health-care professionals and retailers should stop supplying the said product to their clients. People who have used the affected product should consult health-care providers if in doubt or feeling unwell.

     "Contravention of the Public Health and Municipal Services Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is a fine of $10,000 and three months' imprisonment. The DH will seek the Department of Justice's advice on completion of our investigation."

     The spokesman added, "So far, the DH has not received any adverse reports related to the product."

     Hitpharm has set up a hotline, 2111 3862, to answer related enquiries during office hours. The DH will closely monitor the recall.

Ends/Monday, December 10, 2012
Issued at HKT 19:22

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