Counterfeit Alert & Recall from MHRA
The MHRA issued the following counterfeit alert on Friday, 1 June 2007
Press release
Date: |
01 Jun
2007 |
Time: |
14:00 |
Subject: |
Medicines Alert
and Recall of Casodex
|
Contact: |
Press Office 020
7084 3535/3564 or
press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189 |
The MHRA has been
alerted to a counterfeit batch of
Casodex (Bicalutamide) 50mg tablets (batch
number 65520). This drug is used in
the treatment of patients with prostate
cancer. The MHRA has issued a
drug
alert
to recall this product from the market, to
minimise the risk to patients.
The MHRA was contacted
by a wholesaler, who was offered a
suspicious batch of Casodex by another
wholesaler. This is now subject of a
Class 1 medicines recall, today, 01 June
2007. We take this very seriously and a
criminal investigation is being carried
out.
Patients should
contact their pharmacist
as soon as possible if they are taking this
medication, with the batch number of
65520. They should take their medication with
them, so their pharmacist can
check it and return it to the licensed
manufacturer, AstraZeneca, for further
examination. At present there is no evidence
of patients having any adverse
reactions specifically related to the
counterfeits. Patients should consult
their GP if they have any treatment or health
concerns.
Notes
to Editor
1. Casodex
contains the active ingredient called
Bicalutamide. This drug is used in the
treatment of patients with prostate
cancer. The MHRA is working in conjunction
with AstraZeneca the licence holder.
2. The MHRA
investigation is continuing into this case. At
present we are investigating the possibility
of links with the counterfeit drug
recalls of Zyprexa
(24
May 2007) and
Plavix (25 May
2007)
3. The initial
laboratory tests on the seized counterfeits
(batch 65520) show that the samples contain
approximately 75% of the labelled
active ingredient. A counterfeit may also
contain harmful ingredients. Work is
ongoing to obtain more information about any
additional ingredients in these
counterfeit tablets, but in the meantime we
have issued a recall to minimise the
risks to patients.
4. Counterfeits are notoriously
difficult to detect with the untrained eye and
even experts sometimes require full forensic
laboratory tests to determine
whether a suspect product is indeed a
counterfeit.
5. What are parallel imports? Parallel
imported products are often sold at lower
prices in the EU and are allowed to be
imported and relabelled for sale in the
UK. Parallel imported products have a
marketing authorisation issued by the MHRA.
The repacking and relabelling of parallel
imports are inspected by the MHRA but
the importation and re-distribution takes
place outside the original
manufacturer's supply chain.
Click here to go to the MHRA site
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.