The Food and Drug Administration (FDA) has ordered a recall of 410,000 cans of the popular Japanese indigestion medicine Ohta’s Isan after discrepancies were found between its Chinese and Japanese ingredient labels.
Thirty-seven batches across three product sizes are being recalled by Sept. 18, after a consumer reported that the Japanese labeling of active ingredients on the outer packaging did not match the approved Chinese version, the FDA said yesterday.
The affected batches include 16 batches of the 75g product, 16 batches of the 140g product, and five batches of the 210g product, the agency said.
Photo: Screen grab from Ohta’s Isan’s Web site
FDA official Yang Po-wen (楊博文) said the product, imported by Yuo Shiang Industrial Co, is an over-the-counter drug approved with Chinese labeling.
Because the Japanese labeling was inconsistent, the FDA ordered a recall.
The distributor must complete the recall and submit a corrective report by Sept. 18, or face fines of NT$200,000 to NT$5 million (US$6,547 to US$163,642) under the Pharmaceutical Affairs Act (藥事法), Yang said.
In addition, the labeling inconsistency may constitute a contravention of Article 46 of the act, punishable by fines of NT$30,000 to NT$2 million, he said.
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