Food and Drug Administration inspection finds 23 products from pharmaceutical companies including Synmosa, Five Continents, and Takeda in violation

The Food and Drug Administration, Ministry of Health and Welfare (abbreviated as the FDA) released the results of the second round of a comprehensive investigation into the use of magnesium carbonate (calcium) raw materials by domestic Western medicine manufacturers. From April 13 to April 17, 2015, a total of 48 companies were inspected, and 19 companies with a total of 23 products failed to meet regulations (the list is in the attached table).

The main issue involved the use of food-grade or food additive permit magnesium carbonate (calcium) as the main ingredient. All manufacturers have been required to take the relevant products off the shelves before midnight on April 22 and complete the recall within 30 days (of which 3 pharmaceutical companies have already voluntarily recalled the products involved), with stock sealed and shipments stopped; for excipients, manufacturers all use them after passing batch-by-batch sampling tests in accordance with pharmacopoeia specifications.

Those found by the FDA to be non-compliant have been immediately required to remove the products from the shelves and recall them, and depending on the severity of the violation, they are fined NT$60,000 to NT$300,000 under Article 21 of the Pharmaceutical Affairs Act, or handled under Article 57 of the Pharmaceutical Affairs Act (serious violation of GMP regulations: improvement within a time limit, suspension of production of the products involved, and a fine of NT$30,000 to NT$150,000).

Magnesium carbonate (calcium) raw material is a multi-purpose atypical chemical raw material widely used in pharmaceuticals, food, and industry, and in pharmaceuticals it is mainly used in stomach medicines.