← Alert archive

MHRA alerts issued in 2020

132 alerts.

• Field Safety Notices: 21 to 24 December 2020

  29 Dec 2020 · Field safety notice (devices)

• Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/61

  29 Dec 2020 · Medicines recall/notification · EL (20)A/61

  Class 2
• Field Safety Notices: 14 to 18 December 2020

  21 Dec 2020 · Field safety notice (devices)

• Company led drug alert: Sodium chloride 0.9% Solution for injection (PL 08828/0178)

  18 Dec 2020 · Medicines recall/notification

• Class 2 Medicines Recall: Merck Sharp & Dohme Limited, Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion, EL (20)A/60

  16 Dec 2020 · Medicines recall/notification · EL (20)A/60

  Class 2
• Class 4 Medicines Defect Information, Co-Careldopa 25mg/100mg tablets, (PL 20242/0028), EL (20)A/59

  15 Dec 2020 · Medicines recall/notification · EL (20)A/59

  Class 4
• Field Safety Notices: 07 December to 11 December 2020

  14 Dec 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Generics [UK] Limited t/a Mylan, EL(20)A/58

  14 Dec 2020 · Medicines recall/notification · EL (20)A/58

  Class 4
• Field Safety Notices: 30 November to 4 December 2020

  7 Dec 2020 · Field safety notice (devices)

• Class 3 Medicines Recall: Lupin Healthcare (UK) Limited, Simvador 10mg, 20mg and 40mg Tablets, EL (20)A/57

  3 Dec 2020 · Medicines recall/notification · EL (20)A/57

  Class 3
• Field Safety Notices: 23 to 27 November 2020

  30 Nov 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55

  26 Nov 2020 · Medicines recall/notification · EL (20)A/55

  Class 2
• Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56

  26 Nov 2020 · Medicines recall/notification · EL (20)A/56

  Class 2
• Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/54

  25 Nov 2020 · Medicines recall/notification · EL (20)A/54

  Class 2
• Field Safety Notice: 16 to 20 November 2020

  23 Nov 2020 · Field safety notice (devices)

• Field Safety Notice: 9 to 13 November 2020

  16 Nov 2020 · Field safety notice (devices)

• Class 2 Medicines Recall, Mylan UK Healthcare Ltd, Ancotil 2.5 g/250 ml Solution for Infusion, PL 46302/0116, EL (20) A/53

  12 Nov 2020 · Medicines recall/notification · EL (20)A/53

  Class 2
• Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/52

  11 Nov 2020 · Medicines recall/notification · EL (20)A/52

  Class 2
• Field Safety Notice: 2 to 6 November 2020

  9 Nov 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Kolanticon Gel 200ml, (PL 17509/0084), EL (20) A/51

  9 Nov 2020 · Medicines recall/notification · EL (20)A/51

  Class 4
• Medical Devices Safety Bulletin (MDSB/2020/02)

  5 Nov 2020 · Device safety information

• Field Safety Notice: 26 to 30 October

  2 Nov 2020 · Field safety notice (devices)

• Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD 0.25 microgram capsules (PL 49876/0001), EL (20) A/50

  29 Oct 2020 · Medicines recall/notification · EL (20)A/50

  Class 3
• Field Safety Notice: 19 to 23 October

  26 Oct 2020 · Field safety notice (devices)

• Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032)

  22 Oct 2020 · Medicines recall/notification

• Medical Devices Safety Bulletin (MDSB/2020/01)

  19 Oct 2020 · Device safety information

• Field Safety Notice: 12 to 16 October

  19 Oct 2020 · Field safety notice (devices)

• Class 3 Medicines Recall: Metoprolol 50 mg Tablets (PL 20075/0304), EL (20)A/49

  14 Oct 2020 · Medicines recall/notification · EL (20)A/49

  Class 3
• Class 2 Medicines Recall: Sanofi Epilim 500mg Gastro-Resistant Tablets EL (20)A/48*

  14 Oct 2020 · Medicines recall/notification · EL (20)A/48

  Class 2
• Field Safety Notices: 5 to 9 October 2020

  12 Oct 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Boots Dermacare 1% w/w Hydrocortisone Ointment (Batch 1DD), EL (20)A/47

  6 Oct 2020 · Medicines recall/notification · EL (20)A/47

  Class 2
• Field Safety Notices: 28 September to 02 October 2020

  5 Oct 2020 · Field safety notice (devices)

• Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD Capsules, EL (20) A/46

  29 Sept 2020 · Medicines recall/notification · EL (20)A/46

  Class 3
• Field Safety Notice: 21 to 26 September 2020

  28 Sept 2020 · Field safety notice (devices)

• National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA)

  23 Sept 2020 · National patient safety alert

• Field Safety Notices: 14 to 18 September 2020

  21 Sept 2020 · Field safety notice (devices)

• Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45

  16 Sept 2020 · Medicines recall/notification · EL (20)A/45

  Class 2
• Field Safety Notices: 7 to 11 September 2020

  14 Sept 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44

  10 Sept 2020 · Medicines recall/notification · EL (20)A/44

  Class 4
• Field Safety Notices: 1 to 4 September 2020

  7 Sept 2020 · Field safety notice (devices)

• Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets

  7 Sept 2020 · Medicines recall/notification

  Class 3
• Field Safety Notices: 24 - 28 August 2020

  1 Sept 2020 · Field safety notice (devices)

• Class 4 FMD Medicines Information: WDA(H) 49276 Kingsley Specials Ltd, Multiple Products, (EL (20)A/42)

  1 Sept 2020 · Medicines recall/notification · EL (20)A/42

  Class 4
• Class 2 Medicines Recall: GL Pharma GmbH, Oxylan 40mg prolonged-release tablets, EL (20)A/41

  1 Sept 2020 · Medicines recall/notification · EL (20)A/41

  Class 2
• Field Safety Notices: 17 - 21August 2020

  24 Aug 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Sanofi Fasturtec 7.5 mg, 1.5 mg/ml powder and solvent for concentrate for solution for infusion, EL (20)A/40

  24 Aug 2020 · Medicines recall/notification · EL (20)A/40

  Class 2
• Field Safety Notices: 10 - 14 August 2020

  17 Aug 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: SmofKabiven extra Nitrogen Electrolyte Free, EL (20)A/39, PL 08828/0269

  13 Aug 2020 · Medicines recall/notification · EL (20)A/39

  Class 4
• Field Safety Notices - 31 July - 07 August 2020

  10 Aug 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Huddersfield Pharmacy Specials MS 19055, Phosphates Solution for Infusion 500ml, EL (20)A/38

  10 Aug 2020 · Medicines recall/notification · EL (20)A/38

  Class 2
• Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37

  4 Aug 2020 · Medicines recall/notification · EL (20)A/37

  Class 2
• Field Safety Notices - 27 July - 31 July 2020

  3 Aug 2020 · Field safety notice (devices)

• Class 3 Medicines Recall: Accord-UK Ltd, Digoxin Tablets BP 250 micrograms, EL (20)A/35

  3 Aug 2020 · Medicines recall/notification · EL (20)A/35

  Class 3
• Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34

  29 Jul 2020 · Medicines recall/notification · EL (20)A/34

  Class 2
• Field Safety Notices - 20 July - 24 July 2020

  27 Jul 2020 · Field safety notice (devices)

• Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)

  23 Jul 2020 · Device safety information

• Class 4 Medicines Defect Information: Pfizer Limited, Ecalta 100mg powder for concentrate for solution for infusion, EL (20)A/32

  23 Jul 2020 · Medicines recall/notification · EL (20)A/32

  Class 4
• Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33

  23 Jul 2020 · Medicines recall/notification · EL (20)A/33

  Class 3
• Field Safety Notices - 13 July to 17 July 2020

  20 Jul 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets, EL (20)A/31

  20 Jul 2020 · Medicines recall/notification · EL (20)A/31

  Class 4
• Class 4 Medicines Defect Information: Aspar Pharmaceuticals Limited, Ibuprofen 200mg and 400mg tablets packaged in various liveries, EL (20)A/30

  20 Jul 2020 · Medicines recall/notification · EL (20)A/30

  Class 4
• Class 2 Medicines Recall: Nitrofurantoin 50 mg Tablets, PL 08553/0087, EL (20)A/28

  15 Jul 2020 · Medicines recall/notification · EL (20)A/28

  Class 2
• Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29

  15 Jul 2020 · Medicines recall/notification · EL (20)A/29

  Class 2
• Field Safety Notices - 06 July to 10 July 2020

  13 Jul 2020 · Field safety notice (devices)

• Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)

  10 Jul 2020 · Device safety information

• Field Safety Notices - 29 June to 03 July 2020

  6 Jul 2020 · Field safety notice (devices)

• Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)

  6 Jul 2020 · Device safety information

• Field Safety Notices: 28 June to 2 July 2021

  5 Jul 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Mepacrine Hydrochloride 100 mg Tablets (Batch 85641), EL (20)A/27

  2 Jul 2020 · Medicines recall/notification · EL (20)A/27

  Class 2
• Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)

  30 Jun 2020 · Device safety information

• Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (1ml Vial) EL (20)A/26

  30 Jun 2020 · Medicines recall/notification · EL (20)A/26

  Class 4
• Field Safety Notices - 22 June to 26 June 2020

  29 Jun 2020 · Field safety notice (devices)

• Field Safety Notices - 15 to 19 June 2020

  22 Jun 2020 · Field safety notice (devices)

• Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)

  17 Jun 2020 · Device safety information

• Field Safety Notices - 08 to 12 June 2020

  15 Jun 2020 · Field safety notice (devices)

• Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)

  8 Jun 2020 · Device safety information

• Field Safety Notices - 01 to 05 June 2020

  8 Jun 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles), EL (20)A/25

  8 Jun 2020 · Medicines recall/notification · EL (20)A/25

  Class 2
• Field Safety Notices - 27 to 29 May 2020

  1 Jun 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection, EL (20)A/24

  28 May 2020 · Medicines recall/notification · EL (20)A/24

  Class 4
• Company led drug alert - Duavive (conjugated oestrogen/bazedoxifene acetate) 0.45mg/20mg Modified Release Tablets – EU/1/14/960/001

  27 May 2020 · Medicines recall/notification

• Field Safety Notices - 18 to 22 May 2020

  26 May 2020 · Field safety notice (devices)

• Field Safety Notices - 11 to 15 May 2020

  18 May 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0015 (EL(20)A/23

  12 May 2020 · Medicines recall/notification · EL (20)A/23

  Class 2
• Field Safety Notices - 4 to 8 May 2020

  11 May 2020 · Field safety notice (devices)

• Field Safety Notices - 27 April to 1 May 2020

  4 May 2020 · Field safety notice (devices)

• Field Safety Notices - 20 to 24 April 2020

  27 Apr 2020 · Field safety notice (devices)

• Field Safety Notices - 13 to 17 April 2020

  20 Apr 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) Trading Limited, various products, EL(20)A/22

  20 Apr 2020 · Medicines recall/notification · EL (20)A/22

  Class 4
• Class 4 Medicines Defect Information: Levofloxacin 500mg Tablets, PL 00289/1047 EL (20)A/21

  16 Apr 2020 · Medicines recall/notification · EL (20)A/21

  Class 4
• Field Safety Notices - 6 to 9 April 2020

  14 Apr 2020 · Field safety notice (devices)

• COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)

  10 Apr 2020 · Device safety information

• Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

  8 Apr 2020 · Device safety information

• Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20)

  7 Apr 2020 · Medicines recall/notification · EL (20)A/20

  Class 2
• Field Safety Notices - 30 March to 3 April 2020

  6 Apr 2020 · Field safety notice (devices)

• Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)

  1 Apr 2020 · Device safety information

• Field Safety Notices - 23 to 27 March 2020

  30 Mar 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19

  30 Mar 2020 · Medicines recall/notification · EL (20)A/19

  Class 4
• Field Safety Notices - 16 to 20 March 2020

  23 Mar 2020 · Field safety notice (devices)

• Class 4 FMD Medicines Information: WDA(H) 50340 HMS Wholesale Limited, Multiple Products, (EL (20)A/17)

  19 Mar 2020 · Medicines recall/notification · EL (20)A/17

  Class 4
• Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)

  18 Mar 2020 · Device safety information

• Update: Class 2 Medicines Recall: Esmya 5mg tablets, EU/1/12/750/001-5, (EL(20)A/16)

  18 Mar 2020 · Medicines recall/notification · EL (20)A/16

  Class 2
• Field Safety Notices - 9 to 13 March 2020

  16 Mar 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Aripiprazole 1mg/ml Oral Solution, PL 04569/1667, (EL(20)A/15)

  11 Mar 2020 · Medicines recall/notification · EL (20)A/15

  Class 4
• Field Safety Notices - 2 to 6 March 2020

  9 Mar 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14)

  4 Mar 2020 · Medicines recall/notification · EL (20)A/14

  Class 2
• Field Safety Notices - 24 to 28 February 2020

  2 Mar 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: AOP Orphan Pharmaceuticals AG, Tetrabenazine 25 mg tablets, PL 21344/0015, (EL (20)A/13)

  2 Mar 2020 · Medicines recall/notification · EL (20)A/13

  Class 2
• Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)

  27 Feb 2020 · Device safety information

• Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models

  27 Feb 2020 · Device safety information

• Class 4 Medicines Defect Information: Oxylan Prolonged-release tablets, all strengths (oxycodone hydrochloride), (EL (20)/A12)

  27 Feb 2020 · Medicines recall/notification

  Class 4
• Class 4 Medicines Defect Information: Memantine 10mg Film-Coated Tablets, PL 20416/0260, (EL (20)A/11)

  25 Feb 2020 · Medicines recall/notification · EL (20)A/11

  Class 4
• All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007)

  25 Feb 2020 · Device safety information

• Field Safety Notices - 17 to 21 February 2020

  24 Feb 2020 · Field safety notice (devices)

• Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10)

  24 Feb 2020 · Medicines recall/notification · EL (20)A/10

  Class 4
• Field Safety Notices - 10 to 14 February 2020

  17 Feb 2020 · Field safety notice (devices)

• Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection, PL 20075/0675, (EL (20)A/09)

  17 Feb 2020 · Medicines recall/notification · EL (20)A/09

  Class 4
• Class 2 Medicines recall: Accord-UK Ltd, Gliclazide 40 mg Tablets (Northstar Livery), PL 20075/0687, (EL (20)A/08)

  13 Feb 2020 · Medicines recall/notification · EL (20)A/08

  Class 2
• Class 4 Medicines Defect Information: Atrolak XL Prolonged-release tablets, all strengths (quetiapine fumarate)

  12 Feb 2020 · Medicines recall/notification

  Class 4
• Class 3 FMD Medicines Recall, Beconase Aqueous Nasal Spray, (Beclometasone Dipropionate 50μg), PL 10949/0104, EL (20)A/07

  12 Feb 2020 · Medicines recall/notification · EL (20)A/07

  Class 3
• Field Safety Notices - 3 to 7 February 2020

  10 Feb 2020 · Field safety notice (devices)

• Company led drug alert – Iohexol solution for injection (350mg/ml and 300 mgI/ml)

  6 Feb 2020 · Medicines recall/notification

• Field Safety Notice: 27 to 31 January

  3 Feb 2020 · Field safety notice (devices)

• Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05)

  3 Feb 2020 · Medicines recall/notification · EL (20)A/05

  Class 2
• Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms/5ml Oral Solution EL(20)A/04

  30 Jan 2020 · Medicines recall/notification · EL (20)A/04

  Class 2
• Class 4 Medicines Defect Information: Dr. Reddy's Laboratories (UK) Ltd, Finasteride 5mg Tablets, PL 08553/0261 (EL (20)A/03)

  29 Jan 2020 · Medicines recall/notification · EL (20)A/03

  Class 4
• Field Safety Notice: 20 to 24 January 2020

  27 Jan 2020 · Field safety notice (devices)

• Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg/g gel ▼, EU/1/12/796/001, Picato 500 mcg/g gel ▼, EU/1/12/796/002 (EL (20)A/02)

  23 Jan 2020 · Medicines recall/notification · EL (20)A/02

  Class 2
• Field Safety Notice: 13 to 17 January 2020

  20 Jan 2020 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Advanz Pharma Zapain 30mg/500mg Tablets (Codeine Phosphate /Paracetamol), PL12762/0034, (EL(20)A/01)

  14 Jan 2020 · Medicines recall/notification · EL (20)A/01

  Class 4
• Field Safety Notice: 06 to 10 January 2020

  13 Jan 2020 · Field safety notice (devices)

• Field Safety Notice: 30 December 2019 to 3 January 2020

  7 Jan 2020 · Field safety notice (devices)

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