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Batch recall of Apo-Gliclazide tablet 80mg (with photo)

     The Department of Health (DH) today (August 1) endorsed a licensed drug wholesaler, Hind Wing Co Ltd, to conduct a voluntary recall of one batch (batch number: KE9991) of Apo-Gliclazide tablet 80mg (registration number: HK-51025) from the market due to a potential quality issue.

     The DH today received notification from Hind Wing that the product's manufacturer in Canada, Apotex Inc., had found some batches of the product which might have come into contact with a cotton cleaning wipe during the production process. Apotex Inc. had initiated a recall of the affected batches as a precautionary measure.

     According to Hind Wing, only one of the affected batches (batch number: KE9991) has ever been imported to Hong Kong since October 2012. About 500 bottles (100 tablets each) were supplied to local dispensaries, private doctors and a private hospital. The rest were exported to Macau. The DH has already informed the relevant authority of Macau on details of the recall.

     So far, the DH has not received any adverse reaction report related to the use of the product. The DH's investigation is continuing.

     Apo-Gliclazide tablet 80mg, containing gliclazide, is a prescription pharmaceutical product used for the treatment of diabetes. It can only be supplied by pharmacies under the supervision of a registered pharmacist upon doctors' prescription.

     Hind Wing has set up a hotline (2566 0562) to answer public enquiries. The DH will closely monitor the recall.

     Members of the public who are in doubt should seek advice from their health-care providers.

Ends/Thursday, August 1, 2013
Issued at HKT 17:56


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