Press release: Further recall of counterfeit Lipitor®

Press release

Date:	03 Aug 2006
Time:	15:00
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) has detected a new batch of counterfeit Lipitor tablets in the pharmaceutical supply chain with a different lot number to that covered by our recall notice on 19th July 2006.

The MHRA, in conjunction with Pfizer Limited, is now recalling Lipitor® 20mg tablets bearing the lot number 067404K3.  In July 2005 the agency recalled a specific batch of counterfeit Lipitor® 20mg tablets (lot number 004405K1) and reissued this safety warning on the 19th July 2006 after further packets belonging to this batch were found.

Any patient who has the Lipitor® 20mg product with lot number 067404K3 or lot number 004405K1 anywhere on the pack should stop taking the tablets and contact their pharmacist.

Lipitor® is a prescription-only medicine used to lower cholesterol and reduce the risk of cardiovascular disease.

Danny Lee-Frost, Head of Enforcement at the MHRA said, “This incident highlights the importance of our ongoing surveillance activity which enables us to search for counterfeit medicines. The testing of the counterfeit product indicates that there is no immediate risk to patients, but because it is a counterfeit we can not guarantee its quality. The MHRA advises patients to stop taking tablets from this batch and to contact their pharmacist. 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 previous cases and there is no evidence of an immediate risk to patients. Further laboratory testing is ongoing.
2. Patients are advised to leave 24 hours between taking their last tablet of lot 004405K1 or lot 067404K3 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 counterfeit medicines .
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 (lot 004405K1 or lot 067404K3) 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.