Japan's Century-Old Seirogan (征露丸) SEIROGAN Intestinal Medicine | Drug Recall 111.09

On September 16, ROC year 111, the Food and Drug Administration of the Ministry of Health and Welfare of the Republic of China issued a “Recall Classification Level 2” drug recall notice regarding the Japanese-specific intestinal and diarrhea medicine “DOKUYU SEIROGAN” sold by “Dokuyu Pharmaceutical Co., Ltd.” and “‘KYOKUTO’ SEIROGAN” (also called 征露丸) sold by “Chung Jung Trading Co., Ltd.” Because the main ingredient content of the drugs in the batches listed deviated from specifications, a recall was initiated.

The FDA has required the manufacturers to complete the recall operation before October 12, ROC year 111, and to submit a recall results report and follow-up preventive and corrective measures.

Basic Information on the Drugs to Be Recalled

• Drug / Product name: DOKUYU SEIROGAN
• “KYOKUTO” SEIROGAN “KYOKUTO”
• Drug indication: Used for enteritis and diarrhea.
• Main ingredients: SCOPOLIA EXTRACT, WOOD CREOSOTE, PHELLODENDRON BARK POWDER (EQ TO POWDERED PHELLODENDRON BARK), GERANIUM HERBA POWDER, CITRUS UNSHIU PEEL, GLYCYRRHIZA POWDER
• Drug permit number: 衛部藥輸字第026111號
• 衛署藥輸字第015450號
• Batch numbers: ICA7, GBF9, GCA9, FBC1, IBA7, LBA9, ECC2
• KAA5
• Permit holder: Dokuyu Pharmaceutical Co., Ltd.
• Chung Jung Trading Co., Ltd.
• Main manufacturer: KYOKUTOCO..LTD
• Manufacturer address: 8-10USHIJIMA-SHIN MACHI TOYAMA-CITY TOYAMA 930-0856 JAPAN
• Drug reference photo:

Drug Recall Related Information

• Recall classification[1]:
• Recall document number: September 12, ROC year 111, FDA Drug Word No. 1111409586 (FDA Drug Section)
• September 12, ROC year 111, FDA Drug Word No. 1111409607 (FDA Drug Section)
• Issuance date: September 12, ROC year 111.
• Publication date: September 16, ROC year 111.
• Reason for recall:
• Main ingredient content deviated from specifications, so a recall was initiated.

References

1. Introduction to the “Drug Recall Classification System” and handling measures of the FDA, Ministry of Health and Welfare.
2. Western medicine, medical device, and cosmetics permit inquiry