Taipei, A total of 1 million diabetes drugs manufactured by Taiwan’s pharmaceutical company Standard Chem. & Pharm. CO., LTD are being recalled because they are alleged to contain extraneous material, according to the Taiwan Food and Drug Administration (FDA) on Thursday.
The recall involves two types of drugs, Metformin 500 (batch number: TL092117) and Metformin 850 (batch number: TL180260), which were alleged to contain extraneous material made of fiber, the administration said.
Metformin 500 and Metformin 850, which together comprise a 20 percent market share for this type of drug, are frequently used by diabetic patients, said Hung Kuo-teng (洪國登), head of the FDA’s Medicinal Products Division, at a telephone interview with reporters on Thursday.
As to what exactly the drugs were found to contain, Hung said the Tainan City-based company is now looking into the case and is required to submit an investigative report at the end of this December.
Hung said if the medications are found to contain extraneous material due to the manufacturer’s negligence, the case will proceed as one involving the manufacture of drugs of inferior quality and Standard Chem. & Pharm. CO., LTD will be fined NT$100,000 (US$3,511) as much as NT$50 million.
In addition, Hung said, the manufacturer will be subject to a fine of NT$200,000 to NT$5 million if it fails to recall all of the drugs in question within the required period of time. (Chang Ming-hsuan and Chung Yu-chen)
Source: Focus Taiwan News Channel