Recordati Pharmaceuticals
📋 Case Summary
What happened The MHRA passed to the PMCPA a complaint it had received from a hospital pharmacy manager about a ‘Dear Dispensary Manager’ letter for Tradorec XL (prolonged release tramadol) dated 29 June 2007 and sent by Recordati Pharmaceuticals Ltd. The letter stated that Tradorec XL should be prescribed by brand name and included the claim: “The MHRA advises that as a Prolonged Release product, it should not be substituted with any Sustained Release or Modified Release formulation, whether branded or generic”. The complainant queried whether the MHRA had made such a product-specific statement and noted that the letter’s references did not include a reference to support the MHRA claim (Recordati said reference 3 was present but positioned incorrectly and later corrected). Because the complaint involved an alleged breach of an undertaking from an earlier case (AUTH/2034/8/07), the Director took up that aspect to ensure compliance with undertakings. Recordati said the letter was sent t
📌 Clauses Breached
9.1,9.5