The Food and Drug Administration (FDA) yesterday added two pharmaceutical companies to the ongoing scare centered on Taichung-based Yi Hsing Trading Co (誼興貿易), after they allegedly acquired magnesium carbonate intended for industrial use from the firm to use in the manufacture of stomach medicine.
The agency said the two firms — Jen Chang Sheng Chemical and Pharmaceutical Co (正長生化學製藥) and Mu Tsu Pharmaceutical Chemical Co (木村製藥) — are in Changhua County.
They allegedly used the substance in stomach powder products, including Jen Chang Sheng’s “Jen Chang Sheng Pulvis Stomachicus” (正長生健胃散) with marketing authorization number 003257 and Mu Tsu’s “Stomach Powder” (胃散) with authorization number 024680.
The FDA announcement came one day after three seasoning powder manufacturers in Changhua County were found to have bought magnesium carbonate meant for industrial use from Yi Hsing, using it to produce 39 products.
“Mu Tsu ceased operations on Dec. 9 last year ahead of the FDA’s new policy, implemented on Jan. 1, requiring all pharmaceutical firms to improve the quality of their medical manufacturing in line with the international PIC/S GMP standards [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme],” FDA Division of Risk Management Director Lee Ming-hsin (李明鑫) said.
Companies that fail to do so will be barred from manufacturing and selling drugs and face suspension of their licenses, Lee added.
He said Mu Tsu transferred its drug licenses to another pharmaceutical firm and entrusted that company with the manufacturing of its medical products, adding that the FDA approved the transfer only last week and that no new products have been manufactured so far.
Jen Chang Sheng is currently under suspension, pending improvement of its manufacturing standards, Lee said.
“However, it is believed that there are still 10 batches of potentially tainted Jen Chang Sheng stomach powder, amounting to 900kg, circulating in the market. The last batch was produced on Dec. 8 last year. The drugs have an expiry date in 2018,” he said.
FDA Division of Medicinal Products Director Liu Li-ling (劉麗玲) said while magnesium carbonate is generally used as an excipient — or the substance that is the vehicle or medium for a drug or other active substance — in stomach powders, it must conform to the requirements of medicine ingredients or the manufacturer could be fined up to NT$300,000 and face a prison term of up to a year.
Liu said the FDA has instructed local health bureaus nationwide to recall the potentially tainted products within a month.
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