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Extension of recall of GlaxoSmithKline's Augmentin (with photo)
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     The Department of Health (DH) today (August 2) ordered GlaxoSmithKline Limited (GSK) to recall from shelves two more strengths of its Augmentin, namely the 625mg tablet (registration no.: HK-44027) and the 1g tablet (registration no.: HK-42252), after the company reported that it also detected plasticisers, including diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), in all tablet formulations manufactured in its plant, GSK Worthing, in England.

     A spokesman for the DH explained that following the recall of GSK's Augmentin 375mg tablet here in mid-July, the company began investigation into the matter in England. Lately, they also found plasticisers, respectively up to 5.5 parts per million (ppm) of DIDP and 5.7 ppm of DINP, in some samples of their Augmentin 625mg and 1g tablets.

     "According to GSK's in-house search, the source of the plasticisers was possibly abrasion of the polyvinyl chloride (PVC) plastic tubing used to transfer powder and granules during tablet production. In view of this reported quality defect, the DH ordered extension of the recall to cover all Augmentin tablet formulations manufactured in UK," the spokesman said.

     "We have also assessed that the levels of plasticisers detected are unlikely to cause safety concern if the tablets are taken according to the recommended dosage. In any case, the DH will seek the Department of Justice's advice on possible legal actions on completion of our investigation," the spokesman added.

     GSK has already set up a hotline 3189 8765 for public enquiries.

     "Augmentin 625mg and 1g tablets are antibiotics for the treatment of bacterial infections. Patients who are currently using the drug for treatment ought to consult their attending doctors or pharmacists as soon as possible and should not just stop using the drugs by themselves," the spokesman warned. "Otherwise, there could be implications on both the courses of their diseases under treatment as well as antibiotic resistance development."

     In connection, though the DH has not received notification of related adverse events, anyone who has taken any of the drugs under the recall and is either in doubt or feeling unwell ought to seek professional advice from their healthcare providers.

Ends/Tuesday, August 2, 2011
Issued at HKT 20:09

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