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

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Dear Healthcare Professional,

Batch number	Expiry date	Pack size	First distributed
3103/1 to 3103/20 inclusive	07/2009	28	30 April 2007

The MHRA in conjunction with the EMEA, with assistance from Waymade plc, are recalling any parallel distributed stock of the above batches of Plavix 75mg film coated tablets following the discovery of counterfeit tablets in the legitimate supply chain.

This material has been repacked into English language cartons by Waymade plc. Cartons  being recalled have the above lot numbers on one end flap and the text ‘Parallel distributed and repackaged by Waymade plc Miles Gray Road Basildon Essex SS14 3FR’ adjacent to the carton bar code.

Batch 3103 is a genuine sanofi - aventis and  Bristol Myers Squibb  batch number for which the original unchanged cartons 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.

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 (see download document).

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)