← Alert archive

MHRA alerts issued in 2022

119 alerts.

• Field Safety Notices: 26 to 30 December 2022

  30 Dec 2022 · Field safety notice (devices)

• Field Safety Notices: 19 to 23 December 2022

  23 Dec 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Epiduo 0.1% / 2.5% gel (45 g), EL (22)A/52

  19 Dec 2022 · Medicines recall/notification · EL (22)A/52

  Class 4
• Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo, EL (22)A/51

  6 Dec 2022 · Medicines recall/notification · EL (22)A/51

  Class 4
• Field Safety Notices: 28 November to 2 December 2022

  5 Dec 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50

  5 Dec 2022 · Medicines recall/notification · EL (22)A/50

  Class 4
• Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution, EL (22)A/49

  29 Nov 2022 · Medicines recall/notification · EL (22)A/49

  Class 4
• Field Safety Notices: 21 to 25 November 2022

  28 Nov 2022 · Field safety notice (devices)

• Field Safety Notices: 14 to 18 November 2022

  21 Nov 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Morningside Healthcare Limited, Hyoscine Butylbromide 20 mg Film-coated Tablets, EL (22)A/48

  21 Nov 2022 · Medicines recall/notification · EL (22)A/48

  Class 4
• Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, EL(22)A/47

  16 Nov 2022 · Medicines recall/notification · EL (22)A/47

  Class 4
• Field Safety Notices: 7 to 11 November 2022

  14 Nov 2022 · Field safety notice (devices)

• National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA

  10 Nov 2022 · Medicines recall/notification

  Class 4
• Field Safety Notices: 31 October to 4 November 2022

  8 Nov 2022 · Field safety notice (devices)

• Field Safety Notices: 24 to 28 October 2022

  31 Oct 2022 · Field safety notice (devices)

• Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46

  27 Oct 2022 · Medicines recall/notification · EL (22)A/46

  Class 3
• Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45

  25 Oct 2022 · Medicines recall/notification · EL (22)A/45

  Class 4
• Field Safety Notices: 17 to 21 October 2022

  24 Oct 2022 · Field safety notice (devices)

• National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA

  21 Oct 2022 · National patient safety alert

  Class 1
• Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection, EL(22)A/44

  20 Oct 2022 · Medicines recall/notification · EL (22)A/44

  Class 2
• Field Safety Notices: 10 to 14 October 2022

  17 Oct 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets), EL (22)A/43

  12 Oct 2022 · Medicines recall/notification · EL (22)A/43

  Class 4
• Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL (22)A/42

  11 Oct 2022 · Medicines recall/notification · EL (22)A/42

  Class 2
• Field safety notice (FSN) 03 to 07 October

  10 Oct 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Stemetil 5mg/5ml Syrup, EL(22)A/41

  6 Oct 2022 · Medicines recall/notification · EL (22)A/41

  Class 2
• Field Safety Notices: 26 to 30 September 2022

  3 Oct 2022 · Field safety notice (devices)

• Field Safety Notices: 19 to 23 September 2022

  26 Sept 2022 · Field safety notice (devices)

• Haemodialysis and haemofiltration machines: Actions to take following pressure-related alarms to avoid unintentional alteration of alarm limits DSI/2022/004

  21 Sept 2022 · Device safety information

• Field Safety Notices: 12 to 16 September 2022

  20 Sept 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution, EL(22)A/40

  20 Sept 2022 · Medicines recall/notification · EL (22)A/40

  Class 2
• Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension , EL (22)A/39

  13 Sept 2022 · Medicines recall/notification · EL (22)A/39

  Class 4
• Field Safety Notices: 5 to 9 September 2022

  12 Sept 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Limited, Bezalip Mono 400mg Tablets, EL (22)A/38

  12 Sept 2022 · Medicines recall/notification · EL (22)A/38

  Class 4
• Field Safety Notices: 29 August to 2 September 2022

  5 Sept 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines), EL(22)A/37

  30 Aug 2022 · Medicines recall/notification · EL (22)A/37

  Class 2
• Field Safety Notices: 22 to 26 August 2022

  29 Aug 2022 · Field safety notice (devices)

• Field Safety Notices: 15 to 19 August 2022

  24 Aug 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Dysport 500 Units Powder for Solution for Injection, EL(22)A/36

  22 Aug 2022 · Medicines recall/notification · EL (22)A/36

  Class 2
• Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg and 20 mg film-coated tablets EL (22)A/35

  17 Aug 2022 · Medicines recall/notification · EL (22)A/35

  Class 4
• Field Safety Notices: 8 to 12 August 2022

  15 Aug 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion, EL(22)A/34

  11 Aug 2022 · Medicines recall/notification · EL (22)A/34

  Class 2
• Field Safety Notices: 1 to 5 August 2022

  8 Aug 2022 · Field safety notice (devices)

• Company led medicines recall: Stockport Pharmaceuticals, Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine), CLMR (22)A/06

  8 Aug 2022 · Medicines recall/notification

• National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA

  4 Aug 2022 · National patient safety alert

  Class 1
• Field Safety Notices: 25 to 29 July 2022

  1 Aug 2022 · Field safety notice (devices)

• Field Safety Notices: 18 to 22 July 2022

  25 Jul 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Novo Nordisk Limited, NovoRapid® FlexTouch® 100 units/ml, Saxenda® FlexTouch® (liraglutide) 6mg/ml, EL(22)A/33

  21 Jul 2022 · Medicines recall/notification · EL (22)A/33

  Class 4
• Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch (14 patches), EL(22)A/32

  20 Jul 2022 · Medicines recall/notification · EL (22)A/32

  Class 4
• Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL(22)A/31

  19 Jul 2022 · Medicines recall/notification · EL (22)A/31

  Class 2
• Field Safety Notices: 11 to 15 July 2022

  18 Jul 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Thornton & Ross, Covonia Night Time Formula and Covonia Original Bronchial Balsam, EL(22)A/30

  14 Jul 2022 · Medicines recall/notification · EL (22)A/30

  Class 4
• Field Safety Notices: 4 to 8 July 2022

  11 Jul 2022 · Field safety notice (devices)

• Field Safety Notices: 27 June to 1 July 2022

  4 Jul 2022 · Field safety notice (devices)

• Field Safety Notices: 20 to 24 June 2022

  27 Jun 2022 · Field safety notice (devices)

• Field Safety Notices: 13 to 17 June 2022

  22 Jun 2022 · Field safety notice (devices)

• Company led medicines recall: A.Vogel Ltd, Linoforce granules 12 years plus (THR 13668/0021), CLMR (22)A/05

  22 Jun 2022 · Medicines recall/notification

• Class 4 Medicines Defect Information: Altan Pharma Limited, Phenylephrine 0.08 mg/ml - solution for injection/infusion, EL(22)A/29

  16 Jun 2022 · Medicines recall/notification · EL (22)A/29

  Class 4
• Company led medicines recall: PCCA Limited, Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution (unlicensed medicines), CLMR (22)A/04

  15 Jun 2022 · Medicines recall/notification

• Field Safety Notices: 6 to 10 June 2022

  13 Jun 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Bristol Laboratories Limited, Phenobarbital 60 mg Tablets, EL(22)A/28

  13 Jun 2022 · Medicines recall/notification · EL (22)A/28

  Class 2
• Field Safety Notices: 30 May to 3 June 2022

  7 Jun 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets, EL (22)A/27

  1 Jun 2022 · Medicines recall/notification · EL (22)A/27

  Class 4
• Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion, EL (22)A/26

  31 May 2022 · Medicines recall/notification · EL (22)A/26

  Class 4
• Field Safety Notices: 23 to 27 May 2022

  30 May 2022 · Field safety notice (devices)

• Company led medicines recall: Consilient Health UK Ltd, Invita D3 800 IU Soft Capsules, CLMR (22)A/03

  30 May 2022 · Medicines recall/notification

• National Patient Safety Alert: NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis (NatPSA/2022/004/MHRA)

  26 May 2022 · National patient safety alert

• Class 4 Medicines Defect Information: Orifarm UK Ltd, Loprazolam 1mg Tablets, EL (22)A/25

  26 May 2022 · Medicines recall/notification · EL (22)A/25

  Class 4
• Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A/24

  25 May 2022 · Medicines recall/notification · EL (22)A/24

  Class 2
• Field Safety Notices: 16 to 20 May 2022

  24 May 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23

  17 May 2022 · Medicines recall/notification · EL (22)A/23

  Class 2
• Field Safety Notices: 09 to 13 May 2022

  16 May 2022 · Field safety notice (devices)

• Field Safety Notices: 02 to 06 May 2022

  9 May 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: GlaxoSmithKline UK Ltd, Zovirax I.V. 500 mg, EL (22)A/22

  9 May 2022 · Medicines recall/notification · EL (22)A/22

  Class 4
• Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets, EL(22)A/21

  5 May 2022 · Medicines recall/notification · EL (22)A/21

  Class 2
• Field Safety Notices: 25 to 29 April 2022

  3 May 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20

  28 Apr 2022 · Medicines recall/notification · EL (22)A/20

  Class 2
• Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19

  27 Apr 2022 · Medicines recall/notification · EL (22)A/19

  Class 2
• Field Safety Notices: 18 to 22 April 2022

  25 Apr 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Pfizer Limited, Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations), EL (22)A/18

  21 Apr 2022 · Medicines recall/notification · EL (22)A/18

  Class 4
• Field Safety Notices: 11 to 15 April 2022

  19 Apr 2022 · Field safety notice (devices)

• Field Safety Notices: 4 to 8 April 2022

  11 Apr 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17

  11 Apr 2022 · Medicines recall/notification · EL (22)A/17

  Class 2
• Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Updated position on use in patients with critical limb ischaemia and intermittent claudication DSI/2022/003

  5 Apr 2022 · Device safety information

• Field Safety Notices: 28 March to 1 April 2022

  4 Apr 2022 · Field safety notice (devices)

• National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)

  29 Mar 2022 · National patient safety alert

• Field Safety Notices: 21 to 25 March 2022

  28 Mar 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Pfizer Limited, Accuretic 10/12.5 mg film-coated tablets, EL (22)A/16

  28 Mar 2022 · Medicines recall/notification · EL (22)A/16

  Class 2
• Field Safety Notices: 14 to 18 March 2022

  21 Mar 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection, EL (22)A/15

  17 Mar 2022 · Medicines recall/notification · EL (22)A/15

  Class 4
• Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02

  16 Mar 2022 · Medicines recall/notification

• Field Safety Notices: 7 to 11 March 2022

  15 Mar 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries), EL (22)A/14

  15 Mar 2022 · Medicines recall/notification · EL (22)A/14

  Class 4
• Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22)A/13

  14 Mar 2022 · Medicines recall/notification · EL (22)A/13

  Class 4
• Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12

  10 Mar 2022 · Medicines recall/notification · EL (22)A/12

  Class 4
• Field Safety Notices: 28 February to 4 March 2022

  8 Mar 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11

  7 Mar 2022 · Medicines recall/notification · EL (22)A/11

  Class 2
• Field Safety Notices: 21 to 25 February 2022

  2 Mar 2022 · Field safety notice (devices)

• Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10

  2 Mar 2022 · Medicines recall/notification · EL (22)A/10

  Class 3
• UPDATE: Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09

  23 Feb 2022 · Medicines recall/notification · EL (22)A/09

  Class 4
• Field Safety Notices: 14 to 18 February 2022

  21 Feb 2022 · Field safety notice (devices)

• Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification. DSI/2022/002

  17 Feb 2022 · Device safety information

• Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001

  17 Feb 2022 · Device safety information

• Class 2 Medicines Recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07

  17 Feb 2022 · Medicines recall/notification

  Class 2
• Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial), EL (22)A 08

  17 Feb 2022 · Medicines recall/notification

  Class 2
• Field Safety Notices: 7 to 11 February 2022

  15 Feb 2022 · Field safety notice (devices)

• Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06

  15 Feb 2022 · Medicines recall/notification

  Class 2
• Company led medicines recall: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine), CLMR (22)A/01

  14 Feb 2022 · Medicines recall/notification

• Field Safety Notices: 6 to 10 February 2023

  13 Feb 2022 · Field safety notice (devices)

• Field Safety Notices: 31 January to 4 February 2022

  8 Feb 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05

  3 Feb 2022 · Medicines recall/notification · EL (22)A/05

  Class 4
• Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04

  1 Feb 2022 · Medicines recall/notification · EL (22)A/04

  Class 4
• Field Safety Notices: 24 to 28 January 2022

  31 Jan 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03

  31 Jan 2022 · Medicines recall/notification · EL (22)A/03

  Class 4
• Field Safety Notices: 17 to 21 January 2022

  25 Jan 2022 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Fresenius Kabi Limited, Kabiven Emulsion for Infusion, EL (22)A/02

  25 Jan 2022 · Medicines recall/notification · EL (22)A/02

  Class 4
• Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) IKERVIS 1 mg/mL eye drops, emulsion , EL (22)A/01

  19 Jan 2022 · Medicines recall/notification · EL (22)A/01

  Class 2
• Field Safety Notices: 10 to 14 January 2022

  17 Jan 2022 · Field safety notice (devices)

• Field Safety Notices: 3 to 7 January 2022

  10 Jan 2022 · Field safety notice (devices)

• Field Safety Notices: 2 to 6 January 2023

  10 Jan 2022 · Field safety notice (devices)

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