The Department of Health ordered GlaxoSmithKline Limited to recall from shelves two more strengths of its Augmentin, namely the 625mg tablet and the 1g tablet.
This came after the company reported that it also detected plasticisers, including diisodecyl phthalate and diisononyl phthalate, 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 companybegan investigation into the matter in England. Lately, they also found plasticisers, respectively up to 5.5 parts per million 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 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.
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