The Food and Drug Administration (FDA) yesterday said that another batch of AstraZeneca’s lipid-lowering drug Crestor was found to have been adulterated with counterfeit drugs, so the company has agreed to initiate a recall for all batches on the market.
The administration last weekend confirmed that batch number MV503 of Crestor 10mg film-coated tablets contained counterfeit drugs in similar packaging, and all the medication from that batch was recalled from hospitals and pharmacies.
“The agency received the report about the counterfeit drugs on Thursday last week and immediately launched an investigation; examinations confirmed that there were counterfeit drugs being sold,” administration Director-General Shou-Mei Wu (吳秀梅) said yesterday.
Photo: courtesy of the Taichung Health Bureau
The New Taipei District Prosecutors’ Office took two suspects into custody over the weekend, and they may face up to 10 years in prison or a fine up to NT$100 million (US$3.24 million) for producing counterfeit drugs under the Pharmaceutical Affairs Act (藥事法).
Another consignment of Crestor 10mg film-coated tablets, batch number MK479, was also found to contain counterfeit drugs, so the FDA said it asked AstraZeneca to recall all batches of the product in the interests of public safety.
“The main ingredient that has been added to the counterfeit drugs is actually another type of lipid-lowering drug, atorvastatin, that used to be commonly prescribed, so people who have taken the counterfeit drugs need not worry too much,” Wu said, adding that people should consult doctors or pharmacists if they have any questions.
According to National Health Insurance (NHI) Administration statistics, more than 200,000 boxes of Crestor are prescribed each month in Taiwan by NHI physicians, administration official Chih Lan-hui (遲蘭慧) said.
AstraZeneca told the administration that it has a sufficient quantity of the medication in stock to replace the recalled products, so patients would not be forced to take other types of drugs, she said.
Asked to respond to media reports that two other types of oral lipid-lowering drugs and one type of oral hypoglycemic drugs had been adulterated with counterfeit drugs and marketed under other brand names, the administration said it did not have any information on the issue, but that prosecutors and the administration would investigate.
An increase in Taiwanese boats using China-made automatic identification systems (AIS) could confuse coast guards patrolling waters off Taiwan’s southwest coast and become a loophole in the national security system, sources familiar with the matter said yesterday. Taiwan ADIZ, a Facebook page created by enthusiasts who monitor Chinese military activities in airspace and waters off Taiwan’s southwest coast, on Saturday identified what seemed to be a Chinese cargo container ship near Penghu County. The Coast Guard Administration went to the location after receiving the tip and found that it was a Taiwanese yacht, which had a Chinese AIS installed. Similar instances had also
GOOD DIPLOMACY: The KMT has maintained close contact with representative offices in Taiwan and had extended an invitation to Russia as well, the KMT said The Chinese Nationalist Party (KMT) would “appropriately handle” the fallout from an invitation it had extended to Russia’s representative to Taipei to attend its international banquet last month, KMT Chairman Eric Chu (朱立倫) said yesterday. US and EU representatives in Taiwan boycotted the event, and only later agreed to attend after the KMT rescinded its invitation to the Russian representative. The KMT has maintained long-term close contact with all representative offices and embassies in Taiwan, and had extended the invitation as a practice of good diplomacy, Chu said. “Some EU countries have expressed their opinions of Russia, and the KMT respects that,” he
VIGILANCE: The military is paying close attention to actions that might damage peace and stability in the region, the deputy minister of national defense said The People’s Republic of China (PRC) might consider initiating a hack on Taiwanese networks on May 20, the day of the inauguration ceremony of president-elect William Lai (賴清德), sources familiar with cross-strait issues said. While US Secretary of State Anthony Blinken’s statement of the US expectation “that all sides will conduct themselves with restraint and prudence in the period ahead” would prevent military actions by China, Beijing could still try to sabotage Taiwan’s inauguration ceremony, the source said. China might gain access to the video screens outside of the Presidential Office Building and display embarrassing messages from Beijing, such as congratulating Lai
Four China Coast Guard ships briefly sailed through prohibited waters near Kinmen County, Taipei said, urging Beijing to stop actions that endanger navigation safety. The Chinese ships entered waters south of Kinmen, 5km from the Chinese city of Xiamen, at about 3:30pm on Monday, the Coast Guard Administration said in a statement later the same day. The ships “sailed out of our prohibited and restricted waters” about an hour later, the agency said, urging Beijing to immediately stop “behavior that endangers navigation safety.” Ministry of National Defense spokesman Sun Li-fang (孫立方) yesterday told reporters that Taiwan would boost support to the Coast Guard