Press Release: Recall of counterfeit Lipitor®

Press release

Date:	19 Jul 2006
Time:	15:20
Subject:	Counterfeit Lipitor
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA), in conjunction with Pfizer Limited, recalled in July 2005 a specific batch of counterfeit Lipitor® 20mg tablets (batch number 004405K1). The agency is reissuing its safety warning, following discovery of more packages of this counterfeit product in the UK pharmaceutical supply chain.

Any patient who has the Lipitor® 20mg product with batch number 004405K1 anywhere on the pack should contact their pharmacist.

Lipitor® is a prescription-only medicine used to lower cholesterol and reduce the risk of cardiovascular disease. Initial tests by the MHRA of the counterfeit material indicate that it does not pose an immediate risk to patients.

Mick Deats, Head of Enforcement and Intelligence at the MHRA said, “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. 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.”

Counterfeit medicines are a global problem and the MHRA has a comprehensive anti-counterfeiting strategy to tackle this type of criminality. The MHRA works closely with national and international regulators and law enforcement agencies, as well as with the pharmaceutical industry, to ensure that tackling counterfeiting medicines remains a priority.

Notes to Editor

1. Initial results of analysis performed by the MHRA on the counterfeits indicate that this material is similar to that examined in the previous case in July 2005. Further laboratory testing is ongoing.

2. Patients are advised to leave 24 hours between taking their last tablet of batch 004405K1 and their first tablet of a new supply of Lipitor® 20mg. The patient will not be aware if their previous medication was genuine or counterfeit.

3. This latest discovery follows active measures by the MHRA to monitor the UK supply chain for the presence of the counterfeit Lipitor®.

4. The MHRA investigates all allegations of counterfeit medicines in the UK, the vast majority of which are not associated with the tightly regulated legitimate supply chain. Action in the form of legal proceedings is taken when appropriate.

5. Pfizer Limited are co-ordinating the collection of Lipitor® 20mg tablets (batch number 004405K1) on behalf of the MHRA.

6. Further information and background about reporting, investigating and recalling suspected defective medicines can be found on our website: www.mhra.gov.uk.