Taiwan Orders Recall of 410,000 Cans of Japanese Medicine

The Food and Drug Administration (FDA) in Taiwan has mandated a recall of approximately 410,000 cans of the popular Japanese indigestion medication, Ohta’s Isan. The recall, affecting 37 batches across three product sizes, is due to inconsistencies between the Chinese and Japanese ingredient labels.

The FDA announced the recall following a consumer report that indicated discrepancies in the labeling of active ingredients on the product’s outer packaging. The agency stated that the Japanese labeling did not align with the approved Chinese version, leading to concerns over consumer safety and product integrity. The last date for the distributor, Yuo Shiang Industrial Co., to complete the recall is set for September 18, 2023.

Details of the Recall

The affected batches include 16 batches of the 75 gram product, 16 batches of the 140 gram product, and five batches of the 210 gram product. FDA official Yang Po-wen explained that the product is classified as an over-the-counter drug that has received approval with Chinese labeling. The inconsistency in labeling prompted the FDA to take action.

Failure to comply with the recall will result in significant penalties. The distributor must submit a corrective report by the deadline or face fines ranging from NT$200,000 (approximately US$6,550) to NT$5 million under the Pharmaceutical Affairs Act. Additionally, the labeling discrepancy may violate Article 46 of the same act, which carries fines between NT$30,000 and NT$2 million.

Consumers who have purchased Ohta’s Isan are advised to check the product labels carefully and return any affected cans to the place of purchase for a refund. The FDA is committed to ensuring the safety and reliability of medications available in Taiwan, and this recall underscores the agency’s vigilance in monitoring product compliance.