The Department of Health (DH) today (September 1) ordered a licensed proprietary Chinese medicines (pCm) wholesaler, Wah Shun Medicine Limited, to recall from shelves its product [W.S] ChuFengT'ouKu Wan (registration number: HKP-01517), as it was found to be tainted by paracetamol, a Western drug, during the DH's routine market surveillance. The Government Laboratory confirmed the amount of paracetamol detected to be a trace amount only.
The pCm under recall is for use by adults for improving blood circulation and bone pain. It is manufactured in the Mainland, then imported into Hong Kong for wholesale by Wah Shun.
The contaminant, paracetamol, is a pharmaceutical product that has long been safely used for its anti-pyretic and analgesic effects.
"Initial investigation by the DH reveals that although Wah Shun was also responsible for secondary packaging of the said product after import, contamination was unlikely as the product was never exposed," a DH spokesman remarked.
"Given that in the Mainland, addition of Western drug ingredients into pCms is permitted, and as only a trace amount of paracetamol was detected, cross-contamination of ingredients during manufacturing or intentional addition could be possibilities here. Hence, the matter has been referred to the Mainland's drug regulatory authority for their upstream investigation," the spokesman commented.
To facilitate the DH's investigation, Wah Shun is also suspending the sale of a related product, [W.S] Kong Kwood Sun Wan (registration number: HKP-02392), which has an identical herbal formula and the same Mainland manufacturer, but bears a different name. The wholesaler has set up a hotline, 2571 0775, for related enquiries.
The DH will be monitoring the recall while continuing with the investigation.
"Though the DH has not received any report of adverse incidents in connection, contravention of Section 52(1) of the Public Health and Municipal Services Ordinance Cap. 132, selling any drug not of the nature, substance or quality demanded by the purchaser, might have occurred here. The maximum penalty involved is $10,000 and three months' imprisonment. In any case, we will work with the Department of Justice regarding possible prosecution on completion of our investigation," the spokesman stated.
"Members of the public who have used the product and are either unsure or feeling unwell should seek advice from their health-care professionals," the spokesman advised.
The DH's records show that Wah Shun has a history of being the wholesaler of another tainted pCm, [W.S] Gan Mao Ling, which had been tainted by arsenic at the time. Prosecution against this case is under way.
Ends/Thursday, September 1, 2011
Issued at HKT 19:04