← Alert archive

MHRA alerts issued in 2014

28 alerts.

• Ebixa 5mg/pump actuation 50ml and 100ml bottle - fault with some of the pump devices

  18 Dec 2014 · Medicines recall/notification

• Amoxil Vials for injection 500mg and 1g, Augmentin Intravenous 600mg and 1.2g - cracks in vials used for packaging

  15 Oct 2014 · Medicines recall/notification

• TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) - identify patients affected recently

  7 Oct 2014 · Device safety information

• All medical devices - ensure system is in place to distribute field safety notices (FSNs)

  26 Sept 2014 · Device safety information

• Ellipse™ VR/DR implantable cardioverter defibrillators (ICDs) - potential failure mode

  16 Sept 2014 · Device safety information

• Motilium 10 10mg Tablets and Motilium Instants10mg – changed to prescription-only medicine

  3 Sept 2014 · Medicines recall/notification

• Idarubicin 1mg/ml injection 5 & 10 ml - recall

  13 Aug 2014 · Medicines recall/notification · EL (14)A/13

• Buccolam Oromucosal Solution - possibility for chemical contamination

  28 Jul 2014 · Medicines recall/notification

• Amoxicillin Sodium 500mg powder for solution for injection - additional reports of injection site reactions in paediatrics and adults

  22 Jul 2014 · Medicines recall/notification · EL (14)A/09

• Midazolam Buccal Liquid 10mg / 1ml, 5ml - screw caps not been correctly placed

  16 Jul 2014 · Medicines recall/notification

• Breast implants - report cases of anaplastic large cell lymphoma (ALCL)

  10 Jul 2014 · Device safety information

• Amoxicillin Sodium 250mg, 500g, & 1mg powder for solution for injection - reports of extravasation and injection site reactions

  9 Jul 2014 · Medicines recall/notification · EL (14)A/09

• Fybogel Hi-Fibre and Fybogel Orange - potential risk of contamination with metal particles

  19 Jun 2014 · Medicines recall/notification · EL (14)A/04

• Clarithromycin 500mg Powder for Solution for Infusion - small particles of white material to be present in individual vials

  18 Jun 2014 · Medicines recall/notification

• Vancomycin Powder for Concentrate for Solution for Infusion - small particles of fibre material and glass in individual vials

  12 Jun 2014 · Medicines recall/notification · EL (14)A/06

• Heated humidifiers used in combination with heated-wire breathing systems - risk of oxygen-fuelled fire

  4 Jun 2014 · Device safety information

• Lipid Phase only of Parenteral Nutrition - potential contamination with Bacillus cereus

  4 Jun 2014 · Medicines recall/notification

• Paradigm ambulatory insulin infusion pumps - risk of hypoglycaemia

  29 May 2014 · Device safety information

• Unicondylar sled knee prosthesis - risk of early wear

  28 May 2014 · Device safety information

• All Pace Medical Inc temporary pacemakers and pacing system analysers (PSAs) – CE marking suspended

  14 May 2014 · Device safety information

• Fybogel Orange - risk of contamination with metal particles

  12 Mar 2014 · Medicines recall/notification · EL (14)A/04

• Insulin infusion pump - risk of delay in treatment

  10 Mar 2014 · Device safety information

• Viread 245 mg film-coated tablets - possible presence of silicone rubber

  6 Mar 2014 · Medicines recall/notification · EL (14)A/03

• Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 - risk of injury

  21 Feb 2014 · Device safety information

• COSOPT preservative-free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container - difficulties with administration

  17 Feb 2014 · Medicines recall/notification · EL (14)A/02

• Class 2 Medicines recall: Actavis Group PTC EHF - Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 (MDR 94-06/18)

  13 Feb 2014 · Medicines recall/notification

  Class 2
• Counterfeit or non-CE marked dental medical devices

  24 Jan 2014 · Device safety information

• Irbesartan / Hydrochorothiazide Teva 300/12.5mg and 300/25mg film-coated tablets - incorrect dosing instruction in patient information leaflet

  8 Jan 2014 · Medicines recall/notification · EL (14)A/01

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