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.
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