Weidalon found to be tainted: gov’t
Industrial-use calcium carbonate allegedly put in stomach powder
Jen Sheng ( ) has become the latest firm to be added to the tainted-medicine scandal after it was allegedly found to be illegally adding industrial calcium carbonate ( ) to a well-known stomach powder, Cheng Shing Tai’s ( ) Weidalon ( ), said Changhua officials last night.
During investigations into industrial magnesium carbonate-tainted products, authorities inadvertently uncovered that I Hsing Trade Company ( ) had been illegally supplying Jen Sheng with calcium carbonate, and produced Weidalon with the chemical as a commission for Cheng Shing Tai from 2008 to 2011. More than 2,000 bottles of the possibly tainted stomach powder have been seized as a precaution.
It is certain that I Hsing had been distributing medicinal ingredients without a license; officials will continue to investigate whether the products were made with industrial-grade substances.
Other pharmaceutical companies allegedly involved in the scandal are Jen Chang Sheng ( ) and Mu Tsu ( ), both of which were raided yesterday and found to be using industrial magnesium carbonate ( ) in their stomach powders.
Problematic medicine includes Jen Chang Sheng’s Jian Stomach Powder ( ) and Mu Tsu’s Stomach Powder ( ).
The Food and Drug Administration (FDA, ) blacklisted the two companies for not abiding by PIC/S standards and failing to pass recent factory inspections.
Jen Chang Shen was shut down earlier this year for not abiding by PIC/S GMP medicine manufacturing standards, said Chairman Ko Jian-an ( ).
the Pharmaceuticals Affairs Act (
) does not regulate the type of magnesium carbonate used in medicine, they had not paid attention to the ingredients used. The company claims to have only discovered they were using industrial magnesium carbonate during yesterday’s investigation.
Supposedly GMP- compliant pharmaceutical company Mu Tsu was shut down last year on Dec. 9. Mu Tsu originally registered as a medicine wholesaler, and recently acquired an FDA manufacturing certificate.
Both companies have ceased manufacturing the products in question. Officials said Mu Tsu’s products should not be found on shelves at all, while the last batch of Jen Chang Sheng’s over-thecounter Jian Stomach Powder was manufactured in August 2013.
Officials estimate at least 900 kilograms of Jen Chang Sheng’s problematic stomach powder are still on shelves nationwide.
The Changhua Health Bureau has notified hospitals and clinics to cease the distribution of tainted products within the month.
The pharmaceutical factories are victims as well, factory workers said, as I Hsing Trade Company ( ), the main firm found distributing industrial magnesium carbonate-made products, had claimed that their products were certified, yet did not mention their status as industrial-grade and not for human consumption.
Vice Health Minister Shiu Mingneng ( ) said that local authorities are still investigating downstream vendors affected by Jen Chang Sheng’s Jian Stomach Powder.
Pharmaceutical companies should use medicine-grade rather than industrial-grade ingredients in excipients, according to the statements from the FDA yesterday.
Failure to abide by the regulations will result in the forcible cessation of production, and in more serious cases, the company’s PIC/S GMP certificate would be made invalid, Shiu said.
Tainted Food Products Still on
Spices made with industrial magnesium carbonate are still on shelves, according to the FDA. Twenty-five products, such as flavored rice powder, cochineal red A ( ), erythrosine (
) and ground pepper should be taken off shelves by midnight today.
Authorities said the investigations uncovered a total of 39 problematic products, 16 affected cities and counties and 171 downstream vendors.
During an investigation yesterday, officials found 25 of the products were still in use.
This photo shows confiscated cans of medicinal products manufactured using industrial magnesium carbonate. Changhua County Health Bureau officials reported that Jen Chang Sheng Jian Stomach Powder ( ) was found to have been made by using industrial magnesium carbonate as excipients, which serve as vehicles for active ingredients. The tainted products were seized by investigators.