US acts against distributor of counterfeit Lipitor and yet more is found in UK

The US Food and Drug Administration (FDA) and the US Attorney for the Western District of Missouri, have indicted 11 individuals, a drug repacker, and two wholesale distributors in cases related to the sale of cholesterol-reducing drug Lipitor.

The indictment made at the end of August, alleges numerous charges including conspiracy to sell counterfeit, illegally imported and misbranded drugs as well as conspiracy to sell stolen drugs.

The conspiracy was said by the FDA to involve 'the manufacture of counterfeit Lipitor at a clandestine facility in Central America, the purchase of genuine Lipitor intended for distribution in South America, and the illegal importation into the US of both products'.

It is believed that the counterfeit Lipitor products are now out of circulation.

In addition, it is alleged in the indictment that members of the conspiracy distributed pharmaceuticals stolen from GlaxoSmithKline and Roche Pharmaceuticals.

Meanwhile in the UK, the MHRA has discovered a second batch of counterfeit Lipitor. The agency said the illegal 40mg copies had been packaged for the UK market but had been intercepted before reaching the legitimate supply chain to pharmacists.

The latest discovery was at a small UK wholesaler, which holds a licence to parallel import - the legal import of drugs from countries where the drugs are substantially cheaper than in the UK. But the MHRA does not believe the copies were imported through a parallel trade route and is instead concentrating tracing its supply route within the UK.

In July, 70 packs of counterfeit Lipitor were found in the UK supply chain after the MHRA received a tip-off from authorities in Rotterdam. Two wholesalers believed to be linked to the distribution of the copies are currently under investigation.

The discovery meant Pfizer was forced to recall 120,000 packs of Lipitor as the 70 packs of counterfeit Lipitor carried the same batch number as the genuine batch.