Hong Kong isn't happy with GlaxoSmithKline ($GSK). Regulators there have ordered the drugmaker to recall an antibiotic roughly a month after they found powdered forms of the drug contaminated by chemicals known as "plasticizers." The new recall order applies to Augmentin tablets, which also were found to be tainted by the chemicals.
Health officials tested the tablets as a follow-up to last month's recall of the powdered Augmentin, which is reconstituted into a liquid for dosing. The substances detected in the Augmentin tablets include diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), the Hong Kong government said. Health officials say the amounts found in the powdered and tablet forms are "unlikely to cause acute harmful effects if taken according to the recommended dosage."
Even so, Hong Kong is weighing legal action against the drugmaker. The state health department says it will ask the Department of Justice for its opinion about pursuing that option. "Since GSK could not provide satisfactory explanation on sources of the plasticizers, the quality of the product is in question," the department said in a statement.
GSK says it has begun an "urgent and thorough investigation" to determine the source of the chemicals. "GSK does not intentionally use any plasticizers in the manufacture of Augmentin," the company said in a statement (as quoted by AFP). The company also noted the amounts found in its products were "significantly lower" than levels considered to be risky for humans.
- read the Hong Kong release
- see the news from Reuters
- get the story from AFP
Related Article:
Hong Kong yanks GSK drug on phthalate levels
