Stomach medicines of 13 firms recalled
A total of 13 pharmaceutical companies in Taiwan have been given a recall order and are facing fines for using food-grade instead of pharmaceutical-grade ingredients in their stomach medicines, the country’s Food and Drug Administration (FDA) said Saturday.
In an inspection of 27 pharmaceutical firms over the past three days, it was found that 13 of them could not prove that the magnesium carbonate or calcium carbonate used in a total of 23 products were certified pharmaceutical ingredients, the FDA said.
When magnesium carbonate and calcium carbonate are used as the major ingredients in pharmaceutical products, those two compounds must be of pharmaceutical grade, which requires a certificate from their suppliers, the FDA explained.
It said the 13 companies, however, were using food-grade compounds as the major ingredients in their stomach medicines, in violation of FDA regulations.
FDA head Chiang Yu-mei 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 April 15.
The FDA has also issued an order to seal the companies’ inventories and suspend their shipments, she said.
Under the Pharmaceutical Affairs Act, the companies will also be fined between NT$ 60,000 (US$1,920) and NT$300,000, the FDA said.
Earlier this month, the FDA began inspecting pharmaceutical companies in the wake of reports that some of them were using magnesium carbonate and calcium carbonate intended for industrial purposes only.
Magnesium carbonate is widely marketed as a health supplement and is also to make medicines for stomach ailments. Its active ingredient, magnesium, is a mineral required for efficient functioning of the human body.