The Food and Drug Administration (FDA) has announced a recall of Fucidin tablets used to treat bacterial infections after impurities were found that exceeded acceptable levels.
The recall of about 440,000 tablets already sold was made public on Wednesday on an FDA Web page dedicated to product recalls.
It covered batch number C97090 of Fucidin tablets, with the license holder listed as Taipei-based MRS Micro-work Co and the manufacturer as Laboratoires LEO in France.
Photo: Screen grab from National Cheng Kung University Hospital’s Web site
Huang Mei-chen (黃玫甄), an official with the FDA’s Medicinal Products Division, yesterday said that the license holder voluntarily notified the agency on July 29 that results from the product’s 24-month stability test showed impurities exceeding the prescribed limit.
The level of impurities must be below 0.10 percent, but the three test results for impurities — 0.17 percent, 0.12 percent and 0.11 percent — exceeded the standard, Huang said.
The company has been ordered to complete the recall by Aug. 30, she said.
Fucidin tablets contain fusidate sodium as the active ingredient and are mainly used to treat infections caused by Gram-positive bacteria and Staphylococci.
In the first five months of this year, they accounted for about 1.51 percent of the domestic market for similar drugs, according to the FDA.
Because other drugs with the same ingredient remain available, those needing drug therapy would not be affected, it said.
Meanwhile, the license holder has also been instructed to submit a report on the situation along with corrective and preventive measures, Huang said.
Failure to carry out the recall could result in fines of NT$200,000 to NT$5 million (US$6,664 to US$166,611) under the Pharmaceutical Affairs Act (藥事法).
Apart from Taiwan, the UK also announced a recall of Fucidin tablets on Aug. 4 “as a precautionary measure” due to the same impurity issue.
“No related adverse event reports or product quality complaints have been received related to this defect,” according to information provided by the British government about the recall.
In Taiwan, no related cases had been reported as of yesterday.
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