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The Department of Health (DH) today (February 22) instructed a licensed medicine wholesaler, The International Medical Company Limited, to recall from consumers three batches (batch numbers: 3560612, 3590612 and 3610612) of Simvastatin-Teva 10mg tablets (registration number: HK-51049) due to a packaging error.
International Medical informed the DH today that it has received a complaint from its client that a box (30 tablets per box) of Simvastatin-Teva 10mg tablets (batch number 3560612) was found to contain Simvastatin-Teva 20mg tablets. The batch number 3560612 is actually a unique batch number of Simvastatin-Teva 20mg tablets. In other words, one outer box intended for 10mg tablets was wrongly printed with the batch number of the 20mg tablets and also packed with the 20mg tablets.
According to the products' manufacturer, Teva Pharmaceutical Works Private Limited Company, in Hungary, the cause of the packaging error is still under investigation, but it may involve two other batches, i.e. 3590612 and 3610612. As a precautionary measure, all Simvastatin-Teva 10mg tablets bearing any of the above three batch numbers should be recalled. So far, only one box of Simvastatin-Teva 10mg tablets was found to have such a packaging error.
The DH's investigation is continuing.
Simvastatin-Teva tablets, containing simvastatin, are prescription medicine indicated for hypercholesterolaemia. Side effects include gastrointestinal disturbances, dizziness, neuropathy and myalgia.
According to International Medical, the affected batches were imported into Hong Kong in December 2012. They were mainly supplied to hospitals of the Hospital Authority, DH clinics, private doctors and pharmacies.
International Medical has set up a hotline, 3904 3799, to answer public enquiries. The DH will closely monitor the recall.
"Members of the public who are using Simvastatin-Teva tablets should take extra caution to check if the stripe pack label of the tablets matches the box label and the prescriber's label. Simvastatin-Teva 20mg tablets are tan in colour with the figure '20' debossed on one side while the 10mg tablets are peach in colour with the figure '10' debossed on one side," a DH spokesman said.
"Those who have used the products should consult their health-care providers if in doubt or feeling unwell," the spokesman said.
Ends/Friday, February 22, 2013
Issued at HKT 20:42
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