Stom­ach medicines of 13 firms re­called

The China Post - - LOCAL -

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.

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