Medicine recalls
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| Total recall of pharmaceutical products manufactured by Celogen Pharma Pvt. Ltd. |
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The Department of Health (DH) today (April 15) instructed a licensed drug wholesaler, Batou Limited (Batou), to recall from consumers all registered pharmaceutical products manufactured by Celogen Pharma Pvt. Ltd. in India (Celogen) as some of these products have failed to meet relevant pharmacopoeial standards.
Upon further investigation of the total recall of Celonol 50 tablets ordered by DH on April 5, samples of other registered pharmaceutical products manufactured by the same manufacturer, Celogen, available for sale in Hong Kong were collected for examination. Today, test results showed that samples of three products, namely Celonol 25 tablets, Celevox 500 tablets and Melcicam tablets 7.5mg have exceeded the limit for total bacterial count. Batou was instructed to recall the three products concerned, and as a precautionary measure, all remaining registered pharmaceutical products available in Hong Kong manufactured by Celogen .
A total of 34 pharmaceutical products manufactured by Celogen are registered in Hong Kong. Among these products, 11 products have ever been imported for local sale and distribution (see Annex). These products were supplied to private doctors and dispensaries. All these products are prescription drugs and should only be used under medical supervision. Pharmacies can only sell the drugs under the supervision of a registered pharmacist and upon doctors’ prescription.
Microbial contamination of a pharmaceutical product may not only have the potential to affect the therapeutic efficacy of the product, but may also lead to the risk of infection for the user.
So far, the DH has not received any adverse reaction report in connection with these products.
Batou has set up a hotline (2781 2619) to answer public enquiries. DH will closely monitor the recall.
DH has requested Batou to provide a detailed investigation report on the cause of the incident. DH's investigation is continuing.
The regulatory agency in India has been informed of the incident.
The DH has also written to healthcare professionals to alert them of the recall and to advise them to stop supplying the products to patients.
"According to the Public Health and Municipal Services Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser is an offence. The maximum penalty upon conviction is a fine of $10,000 and three months' imprisonment. " a DH spokesperson said.
"Members of the public who are taking the products should seek advice from their doctors immediately for alternative medications for continued treatment," the spokesperson advised. |
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