The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall for Batch 1183R of Allen and Hanburys - Seretide 250 Evohaler (25 micrograms of salmeterol xinafoate and 250 micrograms of fluticasone propionate per actuation).
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 recommend this batch 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
MHRA understands 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 +44 (0)800 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 +44 (0)808 100 3352.
MHRA understands 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 Defective Medicines Report Centre (DMRC) on +44 (0)20 7084 2574.