This section lists details of new information added to the MHRA website.
The following companies have amended their advertising following MHRA action on complaints to ensure that prescription only medicines are not promoted to the public.
07 Mar 2014 | Company-led drug recall: Thymoglobuline (Anti-thymocyte globulin – rabbit). Vials containing lyophilised powder - Genzyme Europe B. V. - CLDA (14)A03
Genzyme Europe B. V. is recalling batches of Thymoglobuline vials containing lyophilised powder, as a precaution because it is predicted that they will go out of specification before the end of their shelf-life.
06 Mar 2014 | Class 2 Medicines Recall (action within 48 hours): Viread 245 mg Film-Coated Tablets - Gilead Sciences Limited (EL (14)A/03)
Gilead Sciences Limited is recalling specific batches of Viread 245 mg film-coated tablets due to the possible presence of silicone rubber. A failure of equipment used in the manufacture of the active pharmaceutical ingredient formulated in these medicinal product batches may have resulted in damage to silicone gaskets and silicone fragments entering the product in these recalled lots.
04 Mar 2014 | Monthly list of Medical Device Alerts 2014
A month-by-month list of MDAs that we have issued in 2014.
04 Mar 2014 | Nearly one-third of parents in London fail to report drug side-effects experienced by their children to GPs
New research shows that parents in London are the least likely in the UK to tell their GP or pharmacist about the side effects from medicines their children experience.
03 Mar 2014 | Company-led drug recall: Doribax® (doripenem) 500mg powder for solution for infusion - Janssen-Cilag Ltd - CLDA (14)A02
Janssen-Cilag Ltd is recalling Doribax® (doripenem) 500mg powder for solution in the UK. The decision to recall is based on Janssen’s continued portfolio review and follows from the decision to return the licence to Shionogi & Co. Ltd.
The former chief executive of the MHRA, Professor Sir Kent Woods, and Dr Nassim Parvizi, have had their joint article ‘Regulation of medicines and medical devices: contrasts and similarities’ published in Clinical Medicine, the journal of the Royal College of Physicians.
26 Feb 2014 | Medical Device Alert: Peristeen anal irrigation system manufactured by Coloplast Limited (MDA/2014/007)
This Medical Device Alert has been issued as there is a risk of using transanal irrigation inappropriately.
26 Feb 2014 | Medical Device Alert: CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator manufactured by Integra Lifesciences (MDA/2014/006)
The Medical Device Alert has been issued as there is a risk of burns to patient or user. The manufacturer has identified that the blue COAG button on the CUSA® Excel CEM™ nosecone could stick in the ‘activated’ position, this failure can occur whist the device is being used with the CUSA® Excel/Excel+ ultrasonic aspirator.
21 Feb 2014 | GPC transactions of £500 and above during December 2013
GPC transactions of £500 and above during December 2013.