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Press Release

DH orders drug manufacturer to recall wrong labeling products

11 Mar 2009

The Department of Health (DH) today (March 11) instructed Marching Pharmaceutical Ltd. to recall a total of 216 pharmaceutical products (see annex ) as the label expiry dates of these products were not substantiated by laboratory data.

The order was made following DH's thorough investigations into the case which covered scrutiny of the documents containing laboratory data of the products in question and detailed assessment of the application by the manufacturer for de-registration of 120 out of these 216 products.

A DH spokesman said risk assessment made by DH during the course of investigation concluded that the case only involved the stability and not the safety of the pharmaceutical products which were low-risk drugs.

Before DH completing its investigation, the company initiated a recall exercise without DH's proper instruction.

Most of these products are non-prescription products including vitamins, minerals, cough and cold preparations and the remaining are prescription topical preparations such as skin creams.

The manufacturer has set up a hotline 2781 6320 to answer public enquiries on the recall exercise.

Members of the public in possession of any concerned products are advised to contact Marching Pharmaceutical Ltd for detailed arrangement of the recall.

According to the Pharmaceutical Products Recall Guidelines, the manufacturer is required to submit progress and final reports to DH for monitoring purpose.

DH will closely monitor the actions taken in the recall exercise to ensure that all the necessary steps including release the product brand names by the company concerned are effectively and efficiently adhered to.

11 March 2009