MHRA recalls UK batches of “fake Lipitor”

The Medicines and Healthcare products Regulatory Agency (MHRA) has reissued a recall for a specific batch of Lipitor that has proven to be counterfeit.

In July 2005, both the MHRA and Pfizer issued a recall warning for Lipitor batch 004405K1 after it was found that the best-selling drug had been replaced with a counterfeit version.

Although MHRA said the counterfeit version was unlikely to be harmful to health, it has again told any patient being prescribed Lipitor to check the batch number after more fake Lipitor packages were discovered.

The MHRA’s head of enforcement and intelligence, Mick Deats, stated: “It is the vigilance of the MHRA that has led us to identify this counterfeit Lipitor and recall it.”

“Our testing of the counterfeit product indicates that there is no immediate risk to patients, but we can not guarantee its quality.”

Last July, when counterfeit Lipitor was first discovered in the UK, Kate Lloyd, medical director of Pfizer UK, commented: “Patient safety is our top concern and we are seriously alarmed at the discovery of counterfeit medicine in the UK.

“Patient safety is at risk if counterfeit products can easily be introduced into the supply chain through cross border trade, as patients will not gain the benefits their doctor intended when taking their medicine,” she added.

“The MHRA advises patients to stop taking tablets from this batch. If patients have any concerns about possible side effects they should discuss them with their doctor,” he added.

Pfizer claims Lipitor is the most extensively researched statin in the world, having completed studies in over 80,000 patients. According to Forbes, Liptor has been the best-selling drug in the world for the last five years.

Pfizer has had similar problems with counterfeit Lipitor availability in the US.

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