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Po Chai Pills manufacturer ordered to report recall to DH

     In response to media enquiries, a spokesman for the Department of Health (DH) said today (March 25) that the Department has directed Li Chung Shing Tong (Holdings) Ltd HK, a licensed manufacturer of proprietary Chinese medicine, to submit progress reports on recall of its two forms of Po Chai Pills which is under close monitoring by the department.

     Yesterday, DH ordered that all the company's productions, Po Chai Pills Capsule Form and Po Chai Pills Bottle Form, be recalled from local retail outlets and consumers after it learnt that the former was detected by the Singaporean authority to contain the banned cancer-causing drug phenolphthalein and the anti-obesity drug sibutramine.  In Singapore, a recall of the capsule has been ordered since March 8, although it was only notified to DH yesterday.

     DH officials immediately conducted field investigation in the company yesterday.  Staff was examined, documents were searched and products were seized for analysis.

     Findings in hand thus far suggested the source of contamination likely to be in one batch of powder form raw materials used to fill capsules.  It was bought for the first time from a new source in the Mainland in May 2008.  

     A department spokesman said, "We understand that 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 Macao markets.  

     "These are also the only three places in which the capsule form is marketed."  

     Testing by Government Laboratory on samples from both batches confirmed the detection of phenolphthalein and sibutramine.

     DH inspectors also found that the manufacturer had actually initiated recall from the retailers on its own accord earlier on in January, after discovering the presence of the two western pharmaceutical ingredients through its own testing.  However, the action was not reported to the Department.  Neither had the March 8 recall order from the Singaporean authority been made known to DH despite this being stated in the Practising Guildelines For Manufacturers of Proprietary Chinese Medicines.

     The spokesman explained that the recall of all products by Li Chung Shing Tong, comprising all batches of capsule form and pills bottle form, is a precautionary but necessary measure for best protection of Hong Kong's public health because phenolphthalein and sibutramine are potent drugs with known serious side effects.  Moreover, the products are widely and commonly used by our community, with patrons from vulnerable groups including children and the elderly.

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

     "We are working closely with our Mainland and Singaporean counterparts so as to gain a complete picture of the matter," he said.  

     Investigation continues.

Ends/Thursday, March 25, 2010
Issued at HKT 19:25


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