API quality concerns prompt fines and drug recall orders in Taiwan

By Gareth Macdonald

- Last updated on GMT

Fines and product recalls in Taiwan over API concerns
Fines and product recalls in Taiwan over API concerns

Related tags Pharmaceutical drug Pharmacology

Thirteen Taiwanese drugmakers have been fined and ordered to recall products by regulators concerned the APIs they contain are food rather than pharma grade.

The Taiwanese Food and Drug Administration (FDA) announced the recall order and fines last Saturday (here in Chinese​).

Agency officials began inspecting various pharmaceutical sites last week after reports​ some manufacturers were using cheaper food grade magnesium carbonate and calcium carbonate in drug products in place of proper medical grade ingredients.

The FDA explained that 13 of the 27 drugmakers it visited were unable to demonstrate whether the magnesium carbonate and calcium carbonate used in various medicines was of appropriate quality.

The recall applies to 23 products that must be removed from pharmacy shelves by midnight on April 15 according to Taiwan’s Pharmaceutical Affairs Act.

The drugmakers​ – all of which are local firms according to a Taiwan-based expert we asked – have each been fined between NT$60,000 ($1,920) and NT$300,000.

Food grade

Magnesium carbonate is sold as a food additive and nutritional supplement and has been linked to a reduced risk of hip fractures​. 

It is also the active pharmaceutical ingredient (API) in a number of remedies for stomach complaints.

When used as an API, magnesium carbonate must meet higher quality standards than when used as a food ingredient or supplment and suppliers are required to obtain a certificate of compliance.

The substance is associated with a laxative effect at high doses. The Taiwan FDA said it has not received reports of adverse events caused by products covered by the recall order.

The agency did not respond to a request for additional information.

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