Thirteen pharmaceutical companies in Taiwan have been ordered to recall products and are facing fines for using food-grade ingredients instead of pharmaceutical-grade ingredients in stomach medicines, the Food and Drug Administration (FDA) said yesterday.
In an inspection of 27 pharmaceutical firms over the past three days, 13 could not prove that magnesium carbonate or calcium carbonate used in a total of 23 products were certified pharmaceutical ingredients, the agency said.
When magnesium carbonate and calcium carbonate are used as the major ingredients in pharmaceutical products, they must be of pharmaceutical grade, which requires a certificate from their suppliers, the agency said.
It said the 13 companies were using food-grade compounds as the major ingredients in their stomach medicines, in violation of FDA regulations.
FDA Director-General Chiang Yu-mei (姜郁美) said the 13 companies have been given an order to recall all of the problematic products within 30 days, but must ensure that they are removed from store shelves by midnight on Wednesday.
The agency also issued an order to seal the companies’ inventories and suspend their shipments, Chiang said.
Under the Pharmaceutical Affairs Act (藥事法), the companies are to be fined between NT$60,000 and NT$300,000, the agency said.
Earlier this month, the agency began inspecting pharmaceutical companies in the wake of reports that some of them were using magnesium carbonate and calcium carbonate intended for industrial use only.
Magnesium carbonate is widely marketed as a health supplement and is also used to make medicines for stomach ailments.
Its active ingredient, magnesium, is a mineral required for efficient functioning of the body.
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