Class 2 Drug Alert (Action within 48 hours): Allen and Hanburys - Seretide 250 Evohaler (25 micrograms of salmeterol xinafoate and 250 micrograms of fluticasone propionate per actuation) - EL (09)A/12

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Dear Healthcare Professional,

Batch Number	Expiry Date	Pack Size	First Distributed
1183R	06/2009	8 ml pressurised inhalers	9/10/2008

GlaxoSmithKline UK (GSK) and MHRA are recalling all remaining stock of the above batch due to the possible presence of counterfeit inhalers in the legitimate supply chain. Glaxo Wellcome UK Ltd are the marketing authorisation holder but this product is branded as an Allen and Hanburys item.

Analytical testing of counterfeits, with this batch number, has indicated that some parts of the counterfeit product are genuine. Performance tests have demonstrated that there could be a reduced patient dose if patients have obtained and used a counterfeit inhaler.

MHRA and GSK advice is that this batch should be recalled from pharmacy and wholesaler level as a precautionary measure.

GSK delivers its UK prescription medicines directly to points of dispensing. If dispensing customers have purchased Seretide Evohalers directly from GSK UK via their appointed Logistics Service Providers (Alliance Healthcare and AAH Pharmaceuticals) they can be confident that they have purchased an authentic product

We understand that the vast majority of genuine inhalers from this batch were probably distributed and supplied several months ago. In order to optimise patient protection, recipients of this alert are requested to quarantine any remaining stocks of this batch, irrespective of where purchased and telephone GSK Customer Contact Centre on 0800 221441 for advice on return and credit.

For any Medical Information enquiries related to this case please call GSK on the above number.

Healthcare Professionals or members of the public can report any safety concerns related to these products to the MHRA Yellow Card scheme. Details for online reporting are provided at http://yellowcard.mhra.gov.uk/. Telephone contact can be made (office hours only) on 0808 100 3352.

We understand that the quoted batch number (1183R) has only been distributed as an originator product to the UK market. If any parallel traders, importers or exporters have concerns about recent transactions with this, or any similar products, they are requested to call the DMRC on 0207 084 2574.

Recipients of this Drug Alert should bring this to the attention of relevant contacts by copy of this letter. Primary Care Trusts are requested to forward this to relevant clinics, General Practitioners and Community Pharmacists.

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)