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Batch recall of Apo-Trifluoperazine Tablet 5mg (with photo)

     The Department of Health (DH) today (July 25) endorsed the voluntary recall of two batches of Apo-Trifluoperazine Tablet 5mg (registration number: HK-09272) from the market by a licensed drug wholesaler, Hind Wing Co Ltd, on quality grounds.

     The DH received notification from Hind Wing today that the product's Canadian manufacturer, Apotex Inc, has decided to recall some batches of Apo-Trifluoperazine Tablet 5mg as they were found to be outside the specification during the post-marketing stability study. According to Hind Wing, only two of the affected batches (batch numbers: JW2265 and JW2266) had been imported into Hong Kong. The active ingredient of batches JW2265 and JW2266 was found to be 91.7 per cent and 92.0 per cent of the label's claim respectively while the specification should be 92.5 per cent to 107.5 per cent.

     The two affected batches were imported into Hong Kong in July 2011 and were supplied to public and private hospitals, private doctors and pharmacies.

     The DH's investigation is continuing.

     Apo-Trifluoperazine Tablet 5mg is a tranquilliser. It can only be sold on prescription and under the supervision of pharmacists at registered pharmacies.

     A DH spokesman said, "The DH has not received any adverse event report in connection with the product so far."

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

     "Here, contravention of Section 52 (1) 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 $10,000 and three months' imprisonment. The DH will seek the Department of Justice's advice on further action upon completion of the investigation.

     "Members of the public who have used the product and are either in doubt or feeling unwell should seek advice from their healthcare professionals," the spokesman said.

Ends/Wednesday, July 25, 2012
Issued at HKT 20:09


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