The Department of Health (DH) today (December 16) agreed that licensed drug wholesaler GlaxoSmithKline Limited (GSK) could re-introduce Augmentin tablets (375mg and 1g) in the Hong Kong market following assessment of investigation and corrective measure reports submitted by GSK.
Augmentin is an antibiotic for the treatment of bacterial infections. It can only be sold by prescription and under the supervision of pharmacists at pharmacies.
A spokesman for the DH explained, "Following the recall of Augmentin tablets in July (375mg) and August (625mg and 1g) in view of the presence of plasticisers, GSK has, upon the DH's request, conducted thorough investigation into the root cause of the incident, and identified that the plasticisers were probably coming from the plastic tubing that came into contact with the materials for producing the tablets in its UK plant.
"After careful assessment and examination of all the reports submitted by GSK including the investigation report, root cause analysis, and corrective and preventive action reports, the DH is satisfied regarding the quality of Augmentin tablets, and thus agrees that the import of Augmentin tablets (375mg and 1g) into Hong Kong can be resumed," the spokesman said.
The DH will stay vigilant about the quality of the products on the market.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201112/16/P201112160249.htm )