Class 1 Drug Alert (action now - including out of hours): Counterfeit parallel distributed product
Plavix Tablets 75mg Film Coated Tablets (Clopidogrel)
New Page 1
DRUG ALERT
Class 1 medicines recall
Action now -
including out of hours
Pharmacy
level recall
25
May 2007 |
EL(07)A/07
|
Our ref:
MDR
36-05/07
|
Dear Healthcare
Professional,
sanofi - aventis,
Bristol Myers Squibb
Plavix Tablets
75 mg Film Coated Tablets
Clopidogrel
EU/1/98/069/001a -
007b
The MHRA in
conjunction with the EMEA, with
assistance from sanofi - aventis and Bristol
Myers Squibb, are recalling any
parallel distributed stock of Lots 3098 and
6Y098 (and lot variants) of
Clopidogrel tablets 75 mg branded as Plavix
following the discovery of
counterfeit tablets in the legitimate supply
chain. Please read the comments
below about lot number variants used in the
parallel distribution trade.
This counterfeit
material was supplied in French livery
via parallel distributors into the UK supply
chain. Counterfeit product may be
present in the UK supply chain alongside
genuine manufactured product. Stock
presenting a patient risk may be present as
French livery cartons with an
overlabel applied by a parallel distributor
or may have been recartoned into an
English carton by the parallel distribution
repacking process.
The above lots are
genuine sanofi - aventis and Bristol
Myers Squibb lot numbers for which the
original unchanged lots were supplied to
France in French livery.
Please note
that sanofi - aventis and Bristol
Myers Squibb routinely supply stock to the UK
market which is not parallel
distributed and is in UK branded livery. This
stock is not affected. None of
this stock has the above lot numbers or
variants.
We have limited
information about this problem and
understand the EMEA has allowed in excess of
30 UK parallel distributors to
supply this product.
Please be aware of the
following issues concerning lot
numbers:
- Parallel
distribution companies may have added a prefix
or suffix to the lot number, such as
6Y098/1 to differentiate different
packing runs. These lot number variants are
included in the scope of the
recall.
- Parallel
distribution companies may occasionally use a
completely different lot number on the
carton. If the lot number on
the carton is not in the format of one of
the quoted batch numbers with or
without a suffix or prefix, recipients are
advised to contact the parallel
distributor listed on the carton for
clarification. We intend to
provide updated data if we receive
additional information.
Actions Required
Recipients are requested to quarantine
the identified lot numbers (3098
and 6Y098 (plus lot variants) and return to
sanofi-aventis at Chapeltown
Distribution Centre, 51 Cart Road,
Chapeltown, Sheffield, South Yorkshire, S35
2PF for examination and suggest you keep full
details of any returns.
During normal working
hours, please telephone Customer
Services (0800 854430), to make arrangements
for return, or Medical Information
(01483 554919), for medical enquiries.
Emergency out of hours number is 01483
505515.
The issue of
reimbursement should be discussed with your
original supplier (not sanofi-aventis or
Bristol Myers Squibb) and we suggest
you keep full records.
Please do not
return stock to your original
supplier but contact sanofi - aventis
Customer Services, who will organise
collection. Your cooperation is requested in
this matter as it will provide
useful information about the origins and
scope of the problem.
Additional information
is available in the Q&As sheet
attached.
Primary Care Trusts are
asked to bring this information to
the attention of Community Pharmacists, GPs
and professionals with an interest
in cardiovascular medicine by copy of this
letter.
Yours
faithfully
Ian Holloway
MHRA DMRC Manager
MHRA Distribution
(further recipients by cascade):
Regional
Contacts for NHS Trusts and
Provider Units
Chief Pharmacists: England, Scotland, Wales,
Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey,
Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to
Independent Health Care Establishments
Primary Care Trusts (England)
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.