U.K. Recall of counterfeit LipitorŪ Batch 004405K1
The MHRA Issued the Following Press Release Today:
Date: 19 Jul 2006
Subject: Counterfeit Lipitor
Contact: Press Office 020 7084 3535/3564 or
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 LipitorŪ 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
Any patient who has the LipitorŪ 20mg product with
batch number 004405K1 anywhere on the pack should
contact their pharmacist.
LipitorŪ 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 LipitorŪ 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
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 LipitorŪ 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 LipitorŪ.
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 LipitorŪ 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:
About The SafeMeds Alert System
The SafeMeds Alert System is a counterfeit alert
distribution service of the the Partnership for Safe
Medicines--a group of
organizations and individuals that have policies,
procedures, or programs to protect consumers from
counterfeit or contraband medicines.