Press Release

Recall of Xeloda Tab 500mg

28 Dec 2011

The Department of Health (DH) today (December 28) endorses the recall of a batch of cancer medicine "Xeloda Tab 500mg" (Registration number: HK-46234) by licensed drug wholesaler Roche Hong Kong Limited (Roche) because of improper preparation of the single active ingredient.

DH received notification from Roche that it is recalling globally two batches of Xeloda Tab 500mg (X0105 and X0106) because in reviewing batch records, a batch of active ingredient, capecitabine, could have been prepared by an unvalidated process. Since the quality of the product could not be ascertained, a recall is initiated as a precautionary measure. The ingredient was manufactured in Roche facility in USA. DH is investigating into the issue of unvalidated process through the US regulatory authority. According to information available so far, the issue affects one batch of Xeloda imported into Hong Kong. The affected batch in Hong Kong is X0106B01.

"Xeloda Tab 500mg" is a prescription medicine for the treatment of colorectal, breast and gastric cancer. It should be dispensed in pharmacy upon doctor prescription.

A total of 35 boxes of the affected batch has been supplied to local private hospitals, private doctors and pharmacies. Another 162 boxes were exported to Macao.

DH has notified the involved hospitals, private doctors and pharmacies, as well as Macao health authority.

Roche has set up a hotline (Tel: 3106 2990) to answer related enquiries.

So far, no adverse event report related to the drug has been received. DH will closely monitor the recall.

Members of the public who are taking the above medicine should consult their healthcare professionals if they feel unwell or are in doubt.