Taiwan FDA seeks Crestor recall after counterfeit finds

AstraZeneca has launched a nationwide recall of its cholesterol-lowering drug Crestor in Taiwan after counterfeits were found in the supply chain.

The Taiwan Food and Drug Administration (FDA) said that since Sunday it has discovered counterfeit Crestor (rosuvastatin) 10mg tablets – bearing the batch numbers MK479 and MV503 – in the supply chain. As a precaution has asked AZ to recall and replace all stocks of the drug in regional hospitals, primary health care centres and pharmacies.

AZ and the FDA will also work together on an audit of regional hospitals and medical centres to try to see if there are other counterfeit batches in circulation. According to local news reports the counterfeits appeared to contain not rosuvastatin but another drug in the same statin class (atorvastatin).

Two suspects involved in introducing the fakes into the supply chain have been arrested and if convicted face up to 10 years in jail and a fine of NT$100m (approximately $3m) fine. More information on the counterfeiting case – including pictures of the fake packs and tablets - can be found on the AZ Taiwan website (in Chinese).