An over-the-counter drug for gastric acid disorder is being pulled from the shelves after it was found to contain an excessive level of aerobic bacteria, the Food and Drug Administration said yesterday.
Food and Drug Administration division head Wang Po-yu (王博譽) told a news conference in Taipei that during the agency’s annual checks it found an irregularity in a batch of the stomach drug marketed as Keenstom Plus Suspension (金十字胃乳液) and produced by Taichung-based Yushen Pharmaceutical Co.
A comprehensive recall has been ordered, Wang said, and an investigation has been launched.
The contamination is suspected to have been caused by inappropriate storage or the use of tainted raw materials during the production process, Wang said, adding that if it is determined to be a “drug of inferior quality,” Yushen would be punished with a fine of up to NT$50 million (US$1.66 million).
Keenstom is used to relieve gastric discomfort, gastric hyperacidity, indigestion and flatulence, according to Yushen.
The excessive aerobic bacteria count could lead to consumers developing moderate diarrhea, Wang said.
The problematic batch amounts to about 4,900 boxes, Yushen said, promising a full recall of the product.
Pharmacist Shen Tsai-ying (沈采穎) was quoted by the Chinese-language Apple Daily as saying that Keenstom accounts for 10 percent of the market for liquid antacids, but only 3 percent of the market for gastrointestinal medicine.
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