The Department of Health (DH) today (August 1) endorsed a licensed drug wholesaler, LF Asia (Hong Kong) Limited - Healthcare Division (LF Asia), to conduct a voluntary recall of one batch (batch number: E12001) of Viartril-S Solution for Injection (Biologici) [Viartril-S] [registration number: HK-60732] from the market due to a potential non-compliance in the Good Manufacture Practice (GMP) of the manufacturer of lignocaine hydrochloride which is one of the ingredients of the product.
DH received notification from LF Asia today that the Italian manufacturer of lignocaine hydrochloride was found not in compliance with the GMP requirements during an inspection by the Italian Medicine Agency. According to information provided by the product manufacturer, although the batch of lignocaine hydrochloride (batch number: 162917) used for manufacturing of the batch (batch number: E12001) of Viartril-S imported into Hong Kong was not affected, a recall is initiated as a precautionary measure. The DH has requested LF Asia to provide a detailed investigation report as soon as possible.
Viartril-S containing glucosamine sulphate and lignocaine hydrochloride is indicated for osteoarthritis. It can only be sold in pharmacy under the supervision of registered pharmacist.
According to LF Asia, 1500 boxes of the affected batch were imported to Hong Kong in November 2012. Among the imported stock, about 570 boxes have been supplied to private doctors and pharmacies. Another 413 boxes were exported to Macao.So far, the DH has not received any adverse reports in connection with the product. The DH's investigation is continuing.
LF Asia has set up hotlines (2635 5448, 2635 5459) to answer related enquiries. The DH will closely monitor the recall.
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