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Recall of proprietary Chinese medicine not complying with labelling and package insert requirements (with photo)

     The Department of Health (DH) today (March 28) instructed a licensed wholesaler of proprietary Chinese medicines (pCms), Luen Shing Medicine Co Ltd, located at 1/F, Hing Lee Industrial Building, 89 Bedford Road, Tai Kok Tsui, Kowloon, to recall from consumers a pCm named [LS] Houjiling (registration number: HKP-02051) as it was found to be not complying with the labelling and package insert statutory requirements during market surveillance.

     According to its label, the pCm is indicated for relieving throat discomfort. The pCm was manufactured in the Mainland and it contained Radix Sophorae Tonkinensis, a Chinese herbal medicine (Chm) specified in Schedule 1 of the Chinese Medicine Ordinance (Cap. 549) (CMO), as one of its active ingredients. Preliminary investigation revealed that it failed to meet the labelling and package insert requirements stipulated in the Chinese Medicines Regulation (Cap. 549F) because the names of more than half of the total number of kinds of active ingredients, the trademark text of the medicine and the precautions on using a pCm containing Schedule 1 Chm of the CMO were absent in the label or package insert.

     "Chms specified in Schedule 1 of the CMO are known to be more potent and contain toxic ingredients, hence extreme caution should be exercised in selling and taking these Chms. Radix Sophorae Tonkinensis contains sophora alkaloids and excessive exposure may cause gastrointestinal problems such as nausea, vomiting and constipation. Thus, registration holders of pCms should list the related precautions on the package inserts to alert the public.

     While the DH's investigation is ongoing, no related adverse reports have been received so far. Luen Shing has set up a hotline at 2393 2898 for related enquiries. The DH will closely monitor the recall.

     "According to Sections 143 and 144 of the CMO, no person shall possess for the purpose of selling any pCm for which the package is not labelled in the prescribed manner or without a package insert which complies with the prescribed requirements. The maximum penalty is $100,000 and two years' imprisonment. Upon completion of the investigation, the DH will work with the Department of Justice on prosecution matters. The DH will also refer this case to the Chinese Medicine Council of Hong Kong for consideration of possible disciplinary action," the spokesman added.

     The spokesman urged members of the public who have the pCm to submit the product to the Chinese Medicine Division of the DH on 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, during office hours for disposal. They should consult health-care professionals if they feel unwell.

Ends/Friday, March 28, 2014
Issued at HKT 19:58


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