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The Department of Health (DH) today (January 16) instructed licensed drug wholesaler The International Medical Co. Ltd. (International) to recall a batch of Allopurinol-Teva Tablets 100mg (registration number: HK-57739; batch number: 1580211) from the shelf on quality ground as black substances were found on some tablets in two blisters of the product.
Through its surveillance system, the DH received notification from the Hospital Authority (HA) on January 14 that black substances were found on some tablets of the product. DH commenced investigation immediately.
Today, investigation results showed that no fungal elements were found. Report from the Government Laboratory today reveals that the black substances, which adhered on the surfaces of some tablets, bear similar features as used hydrocarbon oil.
Hydrocarbon oil might be used in equipment for the production of tablets. DH is investigating why used hydrocarbon oil adhered onto some tablets of the affected batch. According to the information available so far, the black substances were only found on a few tablets of the affected batch and could be due to quality issues.
According to International, the affected batch was manufactured by Teva Pharmaceutical Works Private Ltd Co. in Hungary. A total of 22,965 boxes had been imported into Hong Kong and were supplied to HA, local pharmacies and private doctors.
Allopurinol-Teva Tablets 100mg contains allopurinol. It is indicated mainly for hyperuricaemia and gout. It can be sold in pharmacies under the supervision of pharmacist.
So far, DH has not received any adverse event report in connection with the product. International has set up a hotline 3904 3799 for public enquiries. DH will monitor the recall.
Patients using the tablets are advised to examine the tablets before consumption. If in doubt, they should seek advice from their healthcare professionals.
The DH spokesman says: "Here, contravention of the Public Health and Municipal Services Ordinance (Cap 132), selling 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."
Ends/Monday, January 16, 2012
Issued at HKT 21:24
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