Further recall of antiseptic products (with photos)

     The Department of Health (DH) today (September 25) drew the public's attention to the further recall of antiseptic products.
 
     According to the information provided by the University of Hong Kong, one product named KaruiCare Antiseptic Solution (see photo) tested positive for Burkholderia cepacia complex and Achromobacter. Meanwhile, another product named Bio Cept Antiseptic Solution (see photo) was tested positive for Ralstonia. These products contain 0.05 per cent chlorhexidine, which are not classified as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap 138).
 
     KaruiCare Antiseptic Solution is distributed by Karui (Japan) Co. Limited while Bio Cept Antiseptic Solution is distributed by Sources (U.S.A.) Medicines Ltd. Both companies are voluntarily recalling the products from the market and they have also set up hotlines to answer related enquiries during office hours (please refer to the table below).
 
     Currently, the following eight antiseptic products are being recalled:
 

Distributor Product name Hotline
Sources (U.S.A.) Medicines Ltd Pro-Medi Prosept solution 2411 3463
2411 3182
Smart Medi Chlorhexidine Antiseptic Solution
Dr. MAX’S Chlorhexidine Antiseptic Solution
Bio Cept Antiseptic Solution
Kam Sing Medicine Co. Kam's KS-MED solution 2392 7537
0.05% Chlorhexidine Gluconate Antiseptic Sanitize (KS Medical)
C & L Pharmaceutical Ltd CANCARE AntiSept Solution 2475 9168
Karui (Japan) Co. Limited KaruiCare Antiseptic Solution 3525 1738

  
     As at 4pm today, the DH's Centre for Health Protection (CHP) has recorded no additional patients being affected under the cluster of Burkholderia cepacia complex infection. So far, a total of 184 patients are known to be affected by the infection. Epidemiological investigations are ongoing. So far, the CHP has not received infection cases related to Achromobacter and Ralstonia.
 
     Currently, products containing a low concentration of chlorhexidine not labelled for use on broken skin or wound care are not classified as pharmaceutical products under the Ordinance. Members of the public should not use these products for wound care or on broken skin. The Pharmacy and Poisons Board of Hong Kong will make reference to the overseas regulatory practice of such antiseptic products and consider whether such consumer goods should be regulated as pharmaceutical products. The DH has also strengthened market surveillance and collected products containing a low concentration of chlorhexidine from different brands for micro-organism tests in batches. The tests will take about a few weeks and results will be announced as soon as possible.
    
     The DH's investigations are still on-going.
 
     "Members of the public, especially those who have a weakened immune system, should pay extra attention to personal hygiene. Registered pharmaceutical products should be used and instructions given by healthcare professionals should be followed if they need to carry out wound care on their own. The public should seek medical advice if in doubt," a spokesman for the DH said.

     "Normal saline (solution of 0.9 per cent sodium chloride) is a commonly used cleansing fluid. As it is similar to human body fluid, it does not irritate wound tissues and causes less pain when applied. Antiseptics may irritate the wound or cause an allergic reaction. Generally, a non-infected wound could be cleansed with normal saline and antiseptics are not required, while an infected wound must be managed according to a doctor's instructions," the spokesman added. For more information on wound care, please visit www.elderly.gov.hk/english/healthy_ageing/home_safety/wound_care.html.
 
     "Burkholderia cepacia complex, Achromobacter and Ralstonia are bacteria commonly found in the environment. They are generally not pathogenic to a healthy person, but can cause infections in persons who have a weakened immune system," the spokesman explained.
 
     Members of the public can refer to the appendix for information on registered antiseptic pharmaceutical products containing chlorhexidine as well as sterile saline solution for irrigation. All registered pharmaceutical products should carry a Hong Kong registration number on the package in the format of "HK-XXXXX". People should seek advice from healthcare professionals before using pharmaceutical products.  

Photo  Photo