GlaxoSmithKline ($GSK) turned up plasticizers in two more strengths of its Augmentin antibiotic, triggering another recall in Hong Kong. After recalls of two other versions of the antibiotic, the company launched an internal probe, finding the chemicals in 625-mg and 1-g tablets made at a U.K. plant.
In a statement, GSK reiterated that it doesn't intentionally use the plasticizers--including diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP)--in the manufacturing process. However, it has identified a potential source of the contamination.
"According to GSK's in-house search, the source of the plasticisers was possibly from abrasion of the polyvinyl chloride (PVC) plastic tubing used to transfer powder and granules during tablet production. In view of this reported quality defect, DH orders extension of the recall to cover all Augmentin tablet formulations manufactured in U.K.," according to Hong Kong's Department of Health.
The amount of plasticizers found in the tablets isn't likely to compromise safety as long as consumers take the recommended dosage, health officials said. The department hasn't received any adverse event reports related to the drug. But it's still reserving the right to take legal action against GSK if the Department of Justice finds it warranted.
- read the Health Department release
- get more from GSK
- check out the Macau Daily Times article
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