Medicine recalls
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| Batch recall of Sabril Tablets 500mg |
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The Department of Health (DH) today (July 13) endorsed a licensed drug wholesaler, Sanofi Hong Kong Limited (Sanofi), to recall one batch (batch number: 2991A) of Sabril Tablets 500mg (Hong Kong registration number: HK-35365) from the market due to potential quality issue.
The DH received notification from Sanofi that the overseas manufacturer of the product reported that trace amount of an impurity identified as tiapride was detected in the product. The most probable cause was due to carryover of tiapride on the same equipment during production of active ingredient vigabatrin. The level of tiapride detected was below the permitted daily exposure. As a precautionary measure, Sanofi is voluntarily recalling the affected product from the market.
The above product, containing vigabatrin, is a prescription medicine indicated for the treatment of epilepsy. According to Sanofi, the affected batch has been supplied to the Hospital Authority, local pharmacies and re-exported to Macau.
Sanofi has set up a hotline (2506 8333) to answer related enquiries.
So far, the DH has not received any adverse reaction reports in connection with the affected batch of product. The DH will closely monitor the recall.
Members of the public taking the above products should consult their healthcare professionals if in doubt.
End/Thursday, 13 July 2023 |
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