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Traditional ChineseSimplified ChineseText onlyPDARSS
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February 19, 2010
Drug safety
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Blood-pressure medicine recalled
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Department of Health

The Department of Health is monitoring the recall of a batch of PMS-Carvedilol 12.5mg tablets supplied by pharmaceutical products wholesaler Trenton-Boma.

 

On some of the bottles of the product, the additional label, which the wholesaler has added to comply with the local statutory labelling requirements, states incorrectly each tablet contains 6.25mg carvedilol and shows an incorrect registration number.

 

The registration and batch numbers of the product are HK-52639 and 444937. The product is manufactured in Canada and is used for the treatment of high blood pressure and heart failure. It is a prescription-only medicine.

 

A total of 2,218 bottles (100 tablets per bottle) of the batch have been supplied to the Hospital Authority, and 71 bottles to private doctors and pharmacies.

 

About 230,000 tablets of the concerned batch have been delivered to 10 public hospitals since late December. It is estimated about 30,000 tablets have been dispensed to patients, all with patient-specific dispensing labels carrying dose instructions.

 

The authority will suspend the prescription of the batch in all its pharmacies and provide alternative batches to patients. It will liaise with the department and monitor the situation.

 

The wholesaler has set up a hotline (8101 2716) to answer enquiries. Patients using the product should consult their doctors. The department is investigating the incident.



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