Defective Medicines Report Centre
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Telephone: +44 (0)20 7084 2574 Fax: +44 (0)20 7084 2676
MHRA Distribution: 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)
D R U G A L E R T CLASS 1 MEDICINES RECALL
Action Now – including out of hours
PHARMACY LEVEL RECALL
Date: 25 May 2007
EL(07)A/07
Our Ref: MDR 36-05/07
_________________________________________________________________________
Dear Healthcare Professional,
Counterfeit Parallel Distributed Product Plavix Tablets 75 mg Film Coated Tablets EU/1/98/069/001a – 007b (Clopidogrel)
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.
Waymade plc have added a suffix to the batch number, such as 3103/1 to differentiate different packing runs.
Actions Required Recipients are requested to quarantine the above batch lot numbers and return to Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR for examination and we suggest you keep full details of any returns.
During normal working hours, please telephone Waymade Customer Services on 01268 535200, to make arrangements for return.
The issue of reimbursement should be discussed with Waymade plc. 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
Q&As
Why has a Class 1 Drug Alert been issued in this case?
Initial tests show that samples only contain about 70 – 80% of the labelled active ingredient. In addition, a counterfeit is likely to show a different bioavailability profile and may contain harmful degradants. Work is ongoing to obtain more information but in the interim we consider a recall is needed to minimise patient risk.
Is batch 3103 from any other supplier implicated?
We are not aware of any other suspect parallel distributed material with this batch number. If you have concerns about material from another parallel distributor please contact the parallel distributor listed on the pack.
Why does the licence number have a suffix e.g. “a”?
This indicates that the product should be packaged in PVC blisters.
What is the difference between parallel distribution and parallel imports?
Parallel traded products are often sold at lower prices in the EU and are allowed to be imported and relabelled for sale in the UK. Parallel distributed products have a marketing authorisation issued by the EMEA and parallel imported products have a marketing authorisation issued by the MHRA.
In both cases the repacking and relabelling are inspected by the MHRA but the importation and/or distribution takes place outside the original manufacturer’s supply chain.
http://www.buysafedrugs.info/Reports/recall_plavix_alert1.htm
