MHRA Renews Recall of Counterfeit Lipitor

July 27, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London, www.mhra.gov.uk) has reissued a recall of a specific batch of counterfeit “Lipitor” 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY, www.pfizer.com), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

Mick Deats, MHRA’s head of enforcement and intelligence, said that testing of the counterfeit product revealed “no immediate risk to patients,” but added that the agency “cannot guarantee its quality.” MHRA therefore advises patients to stop taking tablets from the recalled batch and to discuss possible side effects with a doctor. Patients who have packages of 20-mg Lipitor tablets with batch number 004405K1 are urged to contact their pharmacists.

Lipitor is Pfizer’s prescription medicine for lowering cholesterol and reducing patients’ risk of cardiovascular disease. The company is coordinating the collection of the recalled batch on behalf of MHRA.