03 September 2014 Class 2 medicines recall Action within 48 hours Community pharmacy and wholesaler-level recall MDR 49-08/14 Mc Neil Products Limited Motilium 10 10mg Tablets, Motilium Instants 10mg Orodispersible Tablets (domperidone) PL 15513/0347, PL 15513/0350 Johnson & Johnson Ltd., on behalf of the Marketing Authorisation Holder Mc Neil Products Limited, is recalling all unexpired stock of the above products. This follows a Europe-wide review of the safety and efficacy of all domperidone products which has resulted in the conclusion by the UK Commission on Human Medicines (CHM) that products containing domperidone no longer meet the requirements for supply with legal status ‘P’ (i.e. in a pharmacy without prescription, under the supervision of a pharmacist). Remaining stocks of the above products should be quarantined. Pharmacists and wholesalers will be contacted directly by Johnson and Johnson Ltd. Please wait for instructions from Johnson and Johnson Ltd. If you have stock of the above products and have not heard from the company within 10 days of the date on this Drug Alert or if you have returns enquiries after reading the instructions please contact Johnson and Johnson Ltd. Pharmacy Sales Support on 0808 238 978 For medical information enquiries please contact Johnson and Johnson Ltd. Professional Information on 01748 828800 Please note domperidone products with legal status POM are not included in the scope of this recall. Article date: September 2014 Domperidone is a dopamine antagonist with antiemetic properties. It should no longer be sold to anyone without a prescription. It is associated with a small increased risk of serious cardiac side effects (eg, QTc prolongation, torsade de pointes, serious ventricular arrhythmia, and sudden cardiac death). Therefore people need to have a medical assessment before taking domperidone to determine if it is suitable for them. 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