March 25, 2010

The Department of Health has directed licensed proprietary Chinese medicine manufacturer Li Chung Shing Tong (Holdings) Ltd HK to submit progress reports on the recall of its two forms of Po Chai pills.

The department yesterday ordered all the company's Po Chai pills in both capsule and bottle forms removed from local retail outlets and consumers after learning the Singaporean authority had detected the banned cancer-causing drug phenolphthalein and anti-obesity drug sibutramine in the capsule form. Singapore started a recall on March 8, and notified Hong Kong yesterday.

Health department staff questioned the company's employees yesterday, searched documents and seized products for analysis.

So far, investigations suggest the contamination source was likely to be in one batch of powder-form raw materials used to fill the capsules. The company had purchased it from a new Mainland source in May 2008.

The department said it understands two batches of capsules had been produced using the suspicious set of raw materials. One batch (no. 21217) was exported to Singapore, while the other batch (no. 21133) was supplied to Hong Kong and Macau markets. These are the only three places where the capsule form is marketed.

Government tests on samples from both batches confirmed the detection of the two drugs.

The manufacturer, the department found, had actually initiated a recall from the retailers on its own accord in January after discovering the presence of the two Western pharmaceutical ingredients through its own testing. It had not, however, reported this action to the department, nor had it informed the department of the Singapore recall order - even though the practising guidelines for medicine manufacturers make this requirement clear.

Barred from further supply

The department said the recall of all Li Chung Shing Tong products, including the pills in bottle form, is a precautionary but necessary measure for the best protection of public health, as the products are widely and commonly used in the local community, with patrons from vulnerable groups including children and seniors.

The manufacturer has been barred from supplying further stocks of any of its products to the market until it can prove to the department's satisfaction that it has adequate control over the entire production process, particularly on the safety and quality of raw materials used.

The department is working closely with its Mainland and Singaporean counterparts to gain a complete picture of the matter.

 
 
 Source: http://news.gov.hk/en/category/healthandcommunity/100325/html/100325en05010.htm