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In response to media enquiries, a spokesman for the Department of Health (DH) today (June 20) provided an update on the issue relating to an oral product.
The DH, through a press release on June 18, appealed to members of the public not to buy or consume an oral product labelled as "维C银翘片 薄膜衣", without an English name. The product label also shows "深圳同安药业有限公司" and "批准文号：国药准字Z44023281".
The concerned patient referred by the Hospital Authority (HA) was found to have hypokalemia, low blood potassium level, with unknown cause. She described consumption of the above product and submitted its sample to the hospital for analysis. Laboratory testing by the HA indicated that the product contained two undeclared and banned Western drug ingredients, namely phenacetin and aminophenazone. The patient's attending doctor opined that her symptom was not caused by phenacetin and aminophenazone.
According to information provided by the HA, the product bottle submitted by the patient to the hospital contained one white tablet. The patient claimed that the product was purchased in the Mainland in May this year. The DH does not have any record of imports to Hong Kong for sale nor any application for registration as pharmaceutical product of this product.
The DH does not have any remnant of the product sample for further confirmatory test. So far, no other brands have been found to contain undeclared or banned Western drug ingredients. Products of the same name of other manufacturers are not related to the appeal.
According to information provided by the Drug Administration of Shenzhen Municipality (SZDA), laboratory test results by relevant authority on the samples of the same batch bearing the same name as "维C银翘片 薄膜衣" manufactured by Shenzhen Tongan Pharmaceutical Co., Ltd. revealed the absence of phenacetin and aminophenazone.
The DH is currently maintaining close liaison with the China Food and Drug Administration (CFDA) on the issue and a meeting was also held with SZDA officers to follow-up the case. According to the SZDA's information, the "维C银翘片 薄膜衣" manufactured by Shenzhen Tongan Pharmaceutical Co., Ltd. are deep green tablets, which might be different from the white tablet sample submitted by the patient and tested by the HA.
Investigations by the CFDA and the SZDA are proceeding.
Ends/Thursday, June 20, 2013
Issued at HKT 20:22
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