Authorities have discovered a mislabelled, potentially unsafe Chinese medicine on sale in Hong Kong.
The Department of Health is investigating a proprietary Chinese medicine (pCm), Golden Lily Coral Branded Huo Hsiang Cheng Chi Pien, after it was found to be not complying with requirements for labels and package inserts under the Chinese Medicines Regulation during market surveillance.
According to its label, the pCm has actions including reinforcing the ‘healthy qi’ and eliminating summer heat. Preliminary investigations revealed that the pCm was manufactured in the mainland and imported by its registration holder, Hysan Pharmaceutical Company Limited, for local sale.
The pCm contains unprocessed Rhizoma Pinelliae, a Chinese herbal medicine (Chm) specified in Schedule 1 of the Chinese Medicine Ordinance, as one of its active ingredients.
“Initial enquiries showed that the precautions of using a pCm containing a Schedule 1 Chm were absent in the package insert, and the name of the pCm on the label and the package insert did not match the registration record. It therefore failed to meet the label and package insert requirements under the Regulation,” a spokesman for the department said.
“Chms in Schedule 1 are more potent and contain toxic ingredients, and extreme caution should be exercised in selling and taking them. Excessive consumption of unprocessed Rhizoma Pinelliae may cause intense stimulation to the oral and gastrointestinal mucosa, and even generalised numbness and breathing difficulty in serious cases.
“A package insert of a pCm containing Schedule 1 Chm to be sold in Hong Kong shall include precautions to be taken regarding its use to alert the public,” the spokesman said.
PCms not complying with legal requirements for labels and package inserts could convey wrong information and mislead the public. The DH noted that Hysan Pharmaceutical voluntarily recalled all batches of the pCm from consumers and has set up a hotline (2559 0083) for related enquiries.
Investigations are ongoing and the DH will closely monitor the recall. So far, no related adverse reports have been received.
“According to sections 143 and 144 of the CMO, no person shall sell or possess for the purpose of selling any pCm without a label and a package insert in compliance with the prescribed requirements. The maximum penalty is a fine of $100,000 and two years’ imprisonment. We will seek advice from the Department of Justice on prosecution matters upon completion of the investigations, and will also refer the case to the Chinese Medicine Council of Hong Kong for consideration of possible disciplinary action,” the spokesman said.