The Department of Health (DH) today (March 27) ordered the product holder of a proprietary Chinese medicine (pCm), Wong's Young Son Pharmaceuticals Limited, to recall from shelf of a pCm, Flu Fighter (registration no: HKP-05059), as it has been found to have been improperly labelled during market surveillance.
"The label on the package of the pCm showed its dosage should be four capsules taken by every four hours, which is above that registered with the Chinese Medicines Board (CMB). Besides, Radix Sophorae Tonkinensis, which is a Chinese herbal medicine (Chm) specified in Schedule 1 of the Chinese Medicine Ordinance (CMO), is also one of the active ingredients in the pCm formulary but found to be missing from the label. Chm specified in Schedule 1 of CMO are known to contain toxic ingredients and extreme caution should be exercised in selling and taking these medicines, hence required to be listed on the label of a pCm according to the registration requirements of the CMB," a DH spokesman said.
"The pCm is claimed to be used for the prevention and treatment of influenza-like illness. Although the daily intake based on the mislabelled dosage falls below the therapeutic level recommended by literature, we are aware that Radix Sophorae Tonkinensis contains sophora alkaloids and excessive exposure of which may cause gastrointestinal problems such as nausea, vomiting and constipation. Thus, we consider it prudent to alert the public about the possible side effects," the spokesman remarked.
"DH inspectors are now conducting field inspection to ascertain the cause of the mislabel," the spokesman further elaborated.
"So far there is no known related adverse incident report received. Members of the public can call the product holderˇ¦s hotline at 2522 7337 for related enquiries. DH will continue investigation and closely monitor the recall.
"Here, contravention of the CMO (Cap 549), selling a pCm that is not labelled in the prescribed manner, might have occurred. The maximum penalty is $100,000 and two years' imprisonment. Moreover, contravention of the Public Health and Municipal Services Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have also occurred. The maximum penalty involved is a fine of HK$10,000 and three months' imprisonment. DH will seek Department of Justice's advice on completion of our investigation," the DH spokesman stated.
"Members of the public who have used the product should consult their healthcare providers if in doubt or feeling unwell," the spokesman added.
"Should any person possess the above-mentioned pCm, he ought to submit it to the Chinese Medicine Division of the DH at 16/F, Two Landmark East, 100 How Ming Street, Kwun Tong, during office hours for disposal," the spokesman urged.
Ends/Tuesday, March 27, 2012
Issued at HKT 21:57