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Press Release

Recall of Mislabelled Chinese Herbal Medicines

1 November 2012

The Department of Health (DH) today (November 1) ordered a licensed wholesaler in Chinese herbal medicines, Wong Chak Kee Limited (Wong Chak Kee) at Sheung Wan to recall a Chinese herbal medicine, processed Radix Aconiti Lateralis (Bai Fu Pian,白附片) , as it is wrongly labelled as "Giant Typhonium Rhizome/白附子片" in the package, which is corresponding to another Chinese herbal medicine, Rhizoma Typhonii (白附子) in processed form. Wong Chak Kee is the importer of these mislabeled herbal medicines from Mainland China.

The appeal follows the DH's investigation into an adverse event related to the consumption of processed Radix Aconiti Lateralis reported by the Hospital Authority (HA).

On October 20, a 62-year-old gentleman consulted a registered Chinese medicine practitioner (CMP), Mr Leung Ling Chit who worked in a licensed retailer in Chinese herbal medicines, Ka Wah Medicine Co (Ka Wah), in Ma On Shan for upper respiratory infection.

He developed numbness over the limbs, face and tongue, sweating and dizziness, 2 hours after consuming the Chinese herbal medicines which is compatible with the adverse effect of aconitum alkaloid.
"The patient was then admitted to a public hospital for treatment and he is currently in stable condition. Laboratory testing revealed that aconitum alkaloids were found in the urine sample of the patient which is highly likely caused by the use of processed Radix Aconiti Lateralis," a DH spokesman said.

"Preliminary investigation also revealed that both the CMP and Ka Wah misinterpreted and mislabelled processed Radix Aconiti Lateralis as processed Rhizoma Typhonii. Moreover, unused sample of Chinese herbal medicines from the patient was also found to contain processed Radix Aconiti Lateralis.

"While investigation continues, as of today, the processed Radix Aconiti Lateralis was supplied by at least 2 licensed Wholesalers of Chinese herbal medicines, Hang Wo Drug Company (Hang Wo) and Cai Chong Trading Comapny (Cai Chong) at Sheung Wan, which was in turn supplied by Wong Chak Kee.

"Nonetheless, the processed Radix Aconiti Lateralis prescribed and dispensed was within the recommended dosage in Pharmacopoeia of the People’s Republic of China 2010. In addition, no gross contamination of other Chinese medicines has been identified in Ka Wah and no other related adverse incidents were reported so far," the spokesman added.

Processed Radix Aconiti Lateralis (白附片) is a Schedule 2 Chinese herbal medicine used for pain relief. It contains toxic aconitum alkaloids. If used improperly, aconitum alkaloids can cause discomforts like numbness of the mouth and limbs, nausea, vomiting and peripheral weakness, and even lead to life-threatening breathing difficulties and cardiac arrhythmia.

On the other hand, processed Rhizoma Typhonii is another Schedule 2 Chinese herbal medicine used for relieving phlegm congestion and pain. The possible side effects include skin and mucous membrane irritation and central nervous system suppression. It may also be lethal if used improperly," the spokesman said.

"According to Section 7 and 24 of the Chinese Medicines Regulation (Cap 549F), a holder of a retailer and wholesaler license shall ensure that the container of the Chinese herbal medicine has the name of the medicine.

"Contravention is liable to a maximum penalty of $100,000 and two years' imprisonment. Upon completion of the investigation, the DH will work with the Department of Justice on any prosecution matters. DH will also consider referring the case to Chinese Medicine Council for possible disciplinary actions," the spokesman remarked.

"To avoid mislabeling, DH advises all CMP and Chinese medicine traders to follow the names in Schedules 1 and 2 of the Chinese Medicine Ordinance for prescription and labeling of Chinese medicine as well as to comply with relevant Code of Practices and Practicing Guidelines.

"Members of the public can call Wong Chak Kee's hotline at 2546 8754 for enquiries about the recall. The DH will closely monitor the recall," the spokesman said.

The spokesman urged the public to stop using the above mislabeled herbs immediately. Those who have purchased them should submit the products to the Chinese Medicine Division of the DH at 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon during office hours.

Those who have used the mislabeled herbs and feel unwell should seek advice from their healthcare professionals as soon as possible.

The Department of Health (DH) today (November 1) ordered a licensed wholesaler in Chinese herbal medicines, Wong Chak Kee Limited (Wong Chak Kee) at Sheung Wan to recall a Chinese herbal medicine, processed Radix Aconiti Lateralis (Bai Fu Pian,白附片) , as it is wrongly labelled as “Giant Typhonium Rhizome/白附子片” in the package, which is corresponding to another Chinese herbal medicine, Rhizoma Typhonii (白附子) in processed form.

01 November 2012