SafeMeds Alert System

Class 1 Drug Alert (action now - including out of hours): Counterfeit parallel distributed product
Plavix Tablets 75mg Film Coated Tablets (Clopidogrel)

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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


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:

  1. 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.
  2. 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 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.

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