The Department of Health (DH) today (4 March) endorsed a licensed drug wholesaler, Actavis Hong Kong Ltd. (Actavis), to voluntary recall one batch of Rosuvastatin Actavis 5mg Tablets (registration number: HK-62375) from the market due to potential quality issue. The affected batch was F50270.
The DH received notification from Actavis that the manufacturer of the product in Malta found that the impurity content of certain batches of the product has been elevated during the stability study. Although the levels of the impurity were still within specifications, the manufacturer decided to recall the affected batches as a precautionary measure. According to Actavis, only one of these affected batches has been imported into Hong Kong. Since the affected batches did not fail the tests, risk posed by the issue is negligible.
So far, the DH has not received any adverse reports in connection with the product. Investigation is continuing.
Rosuvastatin Actavis 5mg Tablets, containing rosuvastatin, is a prescription medicine used for the treatment of hyperlipidaemia. According to Actavis, about 1244 boxes of 28 tablets of the affected batch had been supplied to a private hospital, private doctors and pharmacies.
Actavis has set up a hotline on 3188 4288 to answer related enquiries. The DH will closely monitor the recall.
