South Korea's drug watchdog said Wednesday that it has suspended the sales of Pfizer's antibiotic azithromycin, sold as Zithromax, for three months due to inaccurate dosage information on its local product labels.
The latest move by the Ministry of Food and Drug Safety is in addition to its earlier recall order on Pfizer Pharmaceutical Korea, the local unit of Pfizer Inc., for its Zithromax 900-milligram dry syrup sold here.
According to the ministry, the prescription drug should be administered mixed with 12 milliliters of water. However, the label erroneously instructs to add 9 milliliters of water instead.
The inaccurate information can lead to an overdose of azithromycin, which is used to treat bacterial infections such as bronchitis, pneumonia and ear infections.
Still, the ministry said it has not received any reports of side effects related to the labeling error.
The ministry said the local unit of Pfizer has so far recalled 4,370 bottles, or 35 percent of 12,498 bottles, sold across the country. The remainder, 8,000 bottles, could not be taken off the market.
The drugmaker blamed the labeling error on unspecified changes to its system at its plant, adding that the issue is limited to labeling.