Taiwan’s FDA orders recall of popular Japanese antidiarrheal drug

Recall notices were issued by the Food and Drug Administration (FDA) on Friday for two brands of Japanese seirogan, a common antidiarrheal drug in Taiwan, informing people that 20 million pills produced in eight batches are to be recalled due to deviations from the drug’s specifications.
One batch of Seirogan Kyokuto, imported by Chung Yung Trading Co., with the designation KAA5, and seven batches of Dokuyu Seirogan, imported by Der Uaw Pharmaceutical Co., with the designations ICA7, CBF9, GCA9, FBC1, IBA7, LBA9, and ECC2 contained ingredients whose amounts deviated from their packaging specifications and are to be recalled by Oct. 12, the FDA said.
Seirogan is a common household drug mainly used to treat diarrhea and inflammations of the digestive tract, said Hung Kuo-teng (洪國登), head of the FDA’s Medicinal Products Division.
The drug is manufactured at the same factory in Japan but imported separately by different Taiwan-based companies, hence the different packaging, he said.
The recall was initiated after Taiwan was informed by the drug’s Japanese manufacturer of an insufficient amount of certain ingredients, Hung said, but the drug maker failed to provide complete test results or numbers.
A total of 20,000 bottles of Seirogan Kyokuto and 100,300 bottles of Dokuyu Seirogan need to be recalled by Oct. 12, the official said.
The importers of the drug are required to provide the FDA with reports on the recalls and measures they will take to prevent similar incidents from occurring, while people with the nonconformant drugs could ask for a refund at the pharmacy where they were purchased, seek advice from pharmacies or doctors near them, or purchase alternative drugs when necessary.

Source: Focus Taiwan News Channel