More than 370,000 Seirogan Toi-A anti-diarrhea tablets imported from Japan are being recalled, as the drug’s active pharmaceutical ingredient (API) manufacturing procedures are not aligned with the originally approved ones, the Food and Drug Administration (FDA) said, as it urged people not to use drugs arbitrarily.
The FDA on Tuesday afternoon said that on Tuesday last week it received a notification from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), saying that the API phellodendron bark extract used in 22 batches was manufactured using methods that were different from what had originally been registered and approved.
The FDA said that the PMDA asked the drug companies to recall the 22 batches, including one batch of Seirogan Toi-A anti-diarrhea tablets exported to Taiwan.
Photo courtesy of the Food and Drug Administration
The Seirogan Toi-A tablets are imported by Taiwan Taiko Pharmaceutical Co Ltd, and are used for the treatment of mild or moderate acute diarrhea and abnormal movement of the intestinal tract. They include three main APIs, including dried phellodendron bark extract.
The FDA said it issued a notice on Wednesday last week recalling the Seirogan Toi-A tablets from batch No. 41RM2, consisting of 374,328 tablets packaged as 24 tablets per box (4,437 boxes) and 36 tablets per box (7,440 boxes).
Hospitals and pharmacies have been informed to stop providing tablets from the batch, while Taiwan Taiko Pharmaceutical Co has been asked to recall the batch before Oct. 27, and to submit a report on its recall results and its follow-up preventive measures, the FDA said.
Meanwhile, the FDA yesterday urged people not to use drugs arbitrarily, saying that they are not a general commodity that can be casually acquired and used.
FDA Medical Products Division deputy head Wu Ming-mei (吳明美) said that some people are used to purchasing drugs on their own when ill, and sometimes friends and family provide leftover drugs from a previous illness.
There are also counterfeit or illegal drugs being sold on online platforms that are often delivered from other countries, she said, adding that according to the Pharmaceutical Affairs Act (藥事法), offenders that manufacture or import fake or illegal drugs could face up to 10 years in prison or a fine up to NT$100 million (US$3.09 million).
FDA Medical Products Division senior specialist Yang Bo-wen (楊博文) said the agency suggests that people avoid improper drug use including believing in other people’s recommendations about the miraculous effects of certain drugs, and instead to seek medical attention or ask a pharmacist.
People should avoid buying drugs from unknown sources and drugs that are not prescribed by doctors, Yang said, adding that they should avoid discontinuing use of prescription drugs on their own; sharing drugs with other people; and hoarding leftover ones.
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