The Department of Health (DH) today (October 7) ordered a licensed proprietary Chinese medicine (pCm) importer and wholesaler, Ocean Pharmaceutical (HK) Limited, to recall its product Cardiotium (pCm registration number: HKNT-00611) from customers as the department has found two undeclared Western drugs in the product.
The case first came to light when the Hospital Authority (HA) noted unexplained improvement in an 85-year-old patient's lipid profile. The man volunteered that he had actually been taking Cardiotium bought over the counter since 2008. Then, as the HA performed chemical analysis on a sample submitted by the patient, two Western medicines, Losartan and Atorvastatin, were found. The case was referred to the DH for investigation.
"Today, the Government Laboratory confirmed the presence of the two said Western medicines in the pCm at therapeutic levels," a DH spokesman revealed.
"On investigation, our pharmaceutical inspectors noted that Cardiotium was made in the Mainland. Ocean imported it, performed secondary packaging here and then assumed the role of wholesaler for local sale afterwards," the spokesman added.
The spokesman said that the medicine is used for managing hypertension, blood lipid and also coronary heart disease.
As for the adulterants, the spokesman stated that Losartan is an antihypertensive agent used for treating heart failure. Side effects can include dizziness, headache and impaired renal function. Atorvastatin is a drug for lowering blood lipid and cholesterol. Its common adverse effects include headache, dizziness, skin rashes and gastrointestinal upset. Both drugs should be used with extra caution in patients with liver impairment.
"Given that in the Mainland, mixing of Western and Chinese drug ingredients is not uncommon, intentional addition was likely as therapeutic dosages were detected in the present case. In any case, the matter has been referred to our Mainland counterpart for their assessment and necessary follow-up," the spokesman said.
Ocean has already set up a hotline at 2508 1248 for related enquiries. The DH will be monitoring the recall besides continuing with the investigation.
"Here, contravention of the Pharmacy and Poisons Ordinance (Cap 138) for the illegal sale of Part I poisons and unregistered pharmaceutical products might have occurred. The maximum penalty for each is $100,000 and two years' imprisonment. Besides, contravention of section 54 of the Public Health and Municipal Services Ordinance, Cap 132, Laws of Hong Kong, selling a drug intended for use by man but unfit for that purpose, might also have occurred. The maximum penalty involved is $50,000 and six months' imprisonment. We will work with the Department of Justice for prosecution consideration on completion of our investigation," the spokesman said.
"Members of the public who have used the product and are either unsure or feeling unwell should seek advice from their healthcare professionals," the spokesman advised.
Ends/Friday, October 7, 2011
Issued at HKT 20:14