← Alert archive

MHRA alerts issued in 2013

48 alerts.

• Irbesartan 300mg film-coated tablets - blisters is incorrectly labelled as Irbesartan 150mg

  23 Dec 2013 · Medicines recall/notification · EL (13)A/32

• Implantable pacemakers - residual longevity overestimated

  19 Dec 2013 · Device safety information

• Methotrexate 25mg/ml injection - damaged vials

  17 Dec 2013 · Medicines recall/notification · EL (13)A/31

• Tixylix® liquid medicines - small pieces of plastic being found in medicine

  13 Dec 2013 · Medicines recall/notification

• Class 4 drug alert (caution in use): Matrifen 100 micrograms/hour Transdermal Patch, Teva UK Livery - Takeda UK Limited (EL (13)A/29)

  12 Dec 2013 · Medicines recall/notification · EL (13)A/29

  Class 4
• Jext 300 and 150 micrograms solution for injection in pre-filled pens - problem with delivery of dosage

  9 Dec 2013 · Medicines recall/notification

• Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG - PL 03551/0069

  5 Dec 2013 · Medicines recall/notification · EL (13)A/27

  Class 4
• Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn

  4 Nov 2013 · Device safety information

• Imigran Injection/Subject - syringes may have needles protruding from the needle shield

  29 Oct 2013 · Medicines recall/notification · EL (13)A/26

• NovoMix 30 Penfill 100U/ml, 3ml and NovoMix 30 FlexPen 100U/ml, 3ml – cartridges contain too much or too little insulin in batches

  25 Oct 2013 · Medicines recall/notification

• Multiple products by Wockhardt UK Limited – 2nd site certificate withdrawn

  17 Oct 2013 · Medicines recall/notification · EL (13)A/19

• Natzon 0.4mg Sublingual Tablets - wrong blister packs in cartons

  26 Sept 2013 · Medicines recall/notification · EL (13)A/23

• Bydureon 2mg powder and solvent - may contain small number of under-filled vials

  16 Sept 2013 · Medicines recall/notification · EL (13)A/22

• Wheeled and non-wheeled walking frames (all models) - potential for detachment of the wheels and/or inadequately tightened screws

  1 Aug 2013 · Device safety information

• Warfarin 3mg tablets - higher than expected levels of degradation

  1 Aug 2013 · Medicines recall/notification

• Intra-oral dental X-ray units: IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510 – wall mount bracket may fail

  18 Jul 2013 · Device safety information

• Multiple products by Wockhardt UK Limited – certificate for manufacturing site withdrawn

  11 Jul 2013 · Medicines recall/notification

• Erythromycin Oral Suspension – manufacturers certificate withdrawn

  11 Jul 2013 · Medicines recall/notification · EL (13)A/20

• Biplane cardiovascular X-ray system (Floor Mounted) - risk of interruption in treatment/procedure

  10 Jul 2013 · Device safety information

• Hydroxyethyl starch (HES) products - increased risk of renal dysfunction and mortality

  27 Jun 2013 · Medicines recall/notification · EL (13)A/18

• Biplane cardiovascular X-ray system - risk of interruption in treatment/procedure

  24 Jun 2013 · Device safety information

• Implantable drug pumps and accessories - risk of drug under- or overdose

  19 Jun 2013 · Device safety information

• AmBisome 50mg Powder for Solution for Infusion - potential lack of sterility assurance

  18 Jun 2013 · Medicines recall/notification · EL (13)A/17

• Ventolin Syrup sugar-free 2mg in 5ml - risk of glass fragments in the bottles

  14 Jun 2013 · Medicines recall/notification · EL (13)A/16

• Questran 4g sachet Powder for Oral Suspension - possible contamination with Enterococcus faecium

  3 Jun 2013 · Medicines recall/notification · EL (13)A/15

• Paradigm ambulatory insulin infusion pumps - risk of compromised insulin therapy

  17 May 2013 · Device safety information

• Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - risk of inadequate external pacing

  9 May 2013 · Device safety information

• Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of the syringe label

  7 May 2013 · Medicines recall/notification

• Retrievable inferior vena cava (IVC) filters - serious complications associated with attempted IVC filter retrieval

  2 May 2013 · Device safety information

• Ativan Injection 4mg/ml - glass particles identified

  2 May 2013 · Medicines recall/notification · EL (13)A/14

• Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of syringe label

  29 Apr 2013 · Medicines recall/notification

• Diazepam 2mg Tablets - does not comply with the required specification

  24 Apr 2013 · Medicines recall/notification

• Miacalcic 200 IU Nasal Spray Solution - withdrawn throughout the European Union

  2 Apr 2013 · Medicines recall/notification

• Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces

  27 Mar 2013 · Device safety information

• GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion

  26 Mar 2013 · Device safety information

• Circadin 2mg prolonged-release tablets – error in patient information leaflet

  20 Mar 2013 · Medicines recall/notification · EL (13)A/10

• ADEPT® 12/14 modular head hip components - higher than expected revision rate

  12 Mar 2013 · Device safety information

• Cytarabine Injection 100mg/ml (1g/10ml) - potential for crystallisation

  6 Mar 2013 · Medicines recall/notification · EL (13)A/09

• Montelukast 5 mg Chewable Tablets - error on the carton

  5 Mar 2013 · Medicines recall/notification · EL (13)A/08

• GoldenEye 0.15% w/w eye ointment – issue with seal integrity and compromised sterility assurance

  27 Feb 2013 · Medicines recall/notification · EL (13)A/06

• Brochlor 1% w/w Eye Ointment – issue with seal integrity and compromised sterility assurance

  27 Feb 2013 · Medicines recall/notification · EL (13)A/07

• Desloratadine ratiopharm 5mg film-coated tablets - higher than expected levels of impurities detected

  26 Feb 2013 · Medicines recall/notification · EL (13)A/04

• Isoline implantable cardioverter defibrillator (ICD) leads - risk of inappropriate shocking, pacing inhibition or shocking inhibition

  21 Feb 2013 · Device safety information

• Infusion pumps: Plum A+ and A+3 family of infusers - risk of interruption in therapy

  20 Feb 2013 · Device safety information

• Dexamfetamine Sulphate 5mg Tablets – packs may contain 3 blister strips instead of 2

  19 Feb 2013 · Medicines recall/notification · EL (13)A/05

• Gygel Contraceptive Jelly – test results did not comply with required specifaction

  29 Jan 2013 · Medicines recall/notification · EL (13)A/03

• Tredaptive modified-release tablets - withdrawn throughout the European Union

  21 Jan 2013 · Medicines recall/notification · EL (13)A/02

• Vimpat 150mg Tablets - blister strips are incorrectly labelled

  8 Jan 2013 · Medicines recall/notification · EL (13)A/01

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