← Alert archive

MHRA alerts issued in 2023

117 alerts.

• Field Safety Notices (FSNs) from 18 to 22 December 2023

  27 Dec 2023 · Field safety notice (devices)

• Field Safety Notices (FSNs) from 11 to 15 December 2023

  19 Dec 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Biocon Pharma UK Ltd., Posaconazole Biocon 100mg Gastro-resistant Tablets, EL(23)A/44

  14 Dec 2023 · Medicines recall/notification · EL (23)A/44

  Class 3
• Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension, EL(23)A/43

  13 Dec 2023 · Medicines recall/notification · EL (23)A/43

  Class 4
• Field Safety Notices: 4 to 8 December 2023

  12 Dec 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Tramadol Hydrochloride 50mg Capsules, Hard, EL (23)A/41

  6 Dec 2023 · Medicines recall/notification · EL (23)A/41

  Class 4
• Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets, EL (23)A/42

  6 Dec 2023 · Medicines recall/notification · EL (23)A/42

  Class 4
• Field Safety Notices: 27 November to 1 December 2023

  4 Dec 2023 · Field safety notice (devices)

• Class 4 Medicines Notification: Teva UK Ltd., Caramet 25/100mg CR Tablets, EL(23)A/40

  4 Dec 2023 · Medicines recall/notification · EL (23)A/40

  Class 4
• Class 3 Medicines Recall: AstraZeneca UK Ltd., Fluenz Tetra nasal spray suspension, EL(23)A/39

  30 Nov 2023 · Medicines recall/notification · EL (23)A/39

  Class 3
• National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA)

  28 Nov 2023 · National patient safety alert

• Field Safety Notices: 20 to 24 November 2023

  27 Nov 2023 · Field safety notice (devices)

• Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection, DSI/2023/11

  24 Nov 2023 · Device safety information

• Field Safety Notices: 13 to 17 November 2023

  22 Nov 2023 · Field safety notice (devices)

• Field Safety Notices: 6 to 10 November 2023

  13 Nov 2023 · Field safety notice (devices)

• Field Safety Notices: 30 October to 3 November 2023

  6 Nov 2023 · Field safety notice (devices)

• Field Safety Notices: 23 to 27 October 2023

  31 Oct 2023 · Field safety notice (devices)

• Field Safety Notices: 16 to 20 October 2023

  25 Oct 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38

  23 Oct 2023 · Medicines recall/notification · EL (23)A/38

  Class 4
• Field Safety Notices: 9 to 13 October 2023

  16 Oct 2023 · Field safety notice (devices)

• SteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, DSI/2023/010

  10 Oct 2023 · Device safety information

• Field Safety Notices: 2 to 6 October 2023

  10 Oct 2023 · Field safety notice (devices)

• Field Safety Notices: 25 to 29 September 2023

  2 Oct 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37

  27 Sept 2023 · Medicines recall/notification · EL (23)A/37

  Class 4
• Field Safety Notices: 18 to 22 September 2023

  25 Sept 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36

  20 Sept 2023 · Medicines recall/notification · EL (23)A/36

  Class 3
• Field Safety Notices: 11 to 15 September 2023

  18 Sept 2023 · Field safety notice (devices)

• Field Safety Notices: 4 to 8 September 2023

  11 Sept 2023 · Field safety notice (devices)

• Company led medicines recall: Sun Pharma UK Ltd, Gemcitabine 10mg/ml Solution for Infusion PL 31750/0062 (Single dose Infusion bag, 2000mg/200ml), CLMR(23)A/06

  7 Sept 2023 · Medicines recall/notification

• Class 4 Medicines Defect Information: Colgate-Palmolive (U.K.) Limited, Duraphat 5000ppm Fluoride Toothpaste (51g), EL (23)A/35

  7 Sept 2023 · Medicines recall/notification · EL (23)A/35

  Class 4
• Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (23)A/34

  5 Sept 2023 · Medicines recall/notification · EL (23)A/34

  Class 3
• No-React® cardiovascular bioprosthesis implantables: discontinuation of CE marking and manufacture. Remaining stock may continue to be used and any adverse incidents reported nationally (DSI/2023/009)

  4 Sept 2023 · Device safety information

• Field Safety Notices (FSNs) from 28 August to 1 September 2023

  4 Sept 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Kyowa Kirin Limited, Tostran (Testosterone, 2% gel), EL (23)A/33

  31 Aug 2023 · Medicines recall/notification · EL (23)A/33

  Class 4
• National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA)

  30 Aug 2023 · National patient safety alert

• Class 2 Medicines Recall: Veriton Pharma Limited, Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS), EL(23)A/32

  30 Aug 2023 · Medicines recall/notification · EL (23)A/32

  Class 2
• Field Safety Notices (FSNs) from 21 to 25 August 2023

  29 Aug 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml), EL (23)A/31

  29 Aug 2023 · Medicines recall/notification · EL (23)A/31

  Class 4
• Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30

  23 Aug 2023 · Medicines recall/notification · EL (23)A/30

  Class 4
• Ethypharm Aurum pre-filled syringes are incompatible with some manufactured needle-free connectors: risk of delay in administering potentially lifesaving medication, DSI/2023/008

  22 Aug 2023 · Device safety information

• Class 4 Medicines Notification, Accord Healthcare Limited, UK, Olmesartan Medoxomil 10mg film coated tablets, EL (23)A/29

  22 Aug 2023 · Medicines recall/notification · EL (23)A/29

  Class 4
• Field Safety Notices (FSNs) from 14 to 18 August 2023

  21 Aug 2023 · Field safety notice (devices)

• Field Safety Notices: 21 to 25 August 2023

  21 Aug 2023 · Field safety notice (devices)

• Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial), EL (23)A/28

  21 Aug 2023 · Medicines recall/notification · EL (23)A/28

  Class 2
• Field Safety Notices: 31 July to 4 August 2023

  7 Aug 2023 · Field safety notice (devices)

• EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs): update of previous quarantine advice after identification of likely cause, DSI/2023/007

  3 Aug 2023 · Device safety information

• Field Safety Notices: 24 to 28 July 2023

  31 Jul 2023 · Field safety notice (devices)

• Class 2 Medicines Recall: B. Braun Medical Ltd, Various Products, EL(23)A/27

  31 Jul 2023 · Medicines recall/notification · EL (23)A/27

  Class 2
• Field Safety Notices: 17 to 21 July 2023

  25 Jul 2023 · Field safety notice (devices)

• Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial), EL (23)A/26

  20 Jul 2023 · Medicines recall/notification · EL (23)A/26

  Class 2
• Field Safety Notices: 10 to 14 July 2023

  19 Jul 2023 · Field safety notice (devices)

• Company led medicines recall: Quantum Pharmaceutical, Diltiazem HCl 2% Cream [unlicensed medicine], CLMR (23)A/05

  19 Jul 2023 · Medicines recall/notification

• Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution, EL(23)A/25

  13 Jul 2023 · Medicines recall/notification · EL (23)A/25

  Class 2
• Class 4 Medicines Notification, Cipla (UK) Limited and Pharmathen S.A., Various Products, EL(23)A24

  12 Jul 2023 · Medicines recall/notification

  Class 4
• Field Safety Notices: 03 to 07 July 2023

  11 Jul 2023 · Field safety notice (devices)

• Class 2 Medicines Recall: Tillomed Laboratories Limited, Labetalol 200mg Tablets, EL(23)A/23

  10 Jul 2023 · Medicines recall/notification · EL (23)A/23

  Class 2
• Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Dacarbazine 100mg, 200mg & 500mg powder for solution for injection vials, EL(23)A/22

  4 Jul 2023 · Medicines recall/notification · EL (23)A/22

  Class 2
• Field Safety Notices: 26 to 30 June 2023

  3 Jul 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Strandhaven Limited T/A Somex Pharma, Sildenafil 100mg Film-coated Tablets, EL(23)A/21

  3 Jul 2023 · Medicines recall/notification · EL (23)A/21

  Class 3
• National Patient Safety Alert: Potential risk of underdosing with calcium gluconate in severe hyperkalaemia (NatPSA/2023/007/MHRA)

  27 Jun 2023 · National patient safety alert

• Field Safety Notices (FSNs) from 19 to 23 June 2023

  26 Jun 2023 · Field safety notice (devices)

• Field Safety Notices (FSNs) from 12 to 16 June 2023

  19 Jun 2023 · Field safety notice (devices)

• Field Safety Notices: 19 to 23 June 2023

  19 Jun 2023 · Field safety notice (devices)

• Field Safety Notices (FSNs) from 5 to 9 June 2023

  13 Jun 2023 · Field safety notice (devices)

• Field Safety Notices (FSNs) from 29 May to 2 June 2023

  6 Jun 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Tricodent Limited (supplier), Medical Oxygen B.P (MEDIGAS OXYGEN B.P), EL (23)A/20

  6 Jun 2023 · Medicines recall/notification · EL (23)A/20

  Class 3
• Field Safety Notices (FSNs) from 22 to 26 May 2023

  29 May 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Drugsrus Limited / Dawa Limited, Metronidazole 200 mg/5 ml Oral Suspension, EL (23)A/19

  23 May 2023 · Medicines recall/notification · EL (23)A/19

  Class 4
• Field Safety Notices: 15 to 19 May 2023

  22 May 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution, EL (23)A/18

  22 May 2023 · Medicines recall/notification · EL (23)A/18

  Class 4
• National Patient Safety Alert: Removal of Philips Health Systems V60 and V60 Plus ventilators from service: risk of shutdown leading to complete loss of ventilation (NatPSA/2023/005/MHRA)

  18 May 2023 · National patient safety alert

• Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion, EL (23)A/17

  16 May 2023 · Medicines recall/notification · EL (23)A/17

  Class 4
• Field Safety Notices: 8 to 12 May 2023

  15 May 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial, EL(23)A/16

  10 May 2023 · Medicines recall/notification · EL (23)A/16

  Class 3
• National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRA

  9 May 2023 · National patient safety alert

  Class 1
• Field Safety Notices: 1 to 5 May 2023

  8 May 2023 · Field safety notice (devices)

• Alert Search Field Safety Notices: 24 to 28 April 2023

  2 May 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15

  26 Apr 2023 · Medicines recall/notification · EL (23)A/15

  Class 4
• Field Safety Notices: 17 to 21 April 2023

  24 Apr 2023 · Field safety notice (devices)

• Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04

  20 Apr 2023 · Medicines recall/notification

• Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14

  20 Apr 2023 · Medicines recall/notification · EL (23)A/14

  Class 4
• Field Safety Notices: 10 to 14 April 2023

  17 Apr 2023 · Field safety notice (devices)

• NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, DSI 2023/006

  11 Apr 2023 · Device safety information

• Field Safety Notices: 3 to 7 April 2023

  11 Apr 2023 · Field safety notice (devices)

• Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid (update to DSI/2023/002), DSI/2023/005

  4 Apr 2023 · Device safety information

• Field Safety Notices: 27 to 31 March 2023

  3 Apr 2023 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg & 100mg film-coated tablets, EL(23)A/13

  30 Mar 2023 · Medicines recall/notification · EL (23)A/13

  Class 4
• Field Safety Notices: 20 to 24 March 2023

  28 Mar 2023 · Field safety notice (devices)

• Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, EL(23)A/12

  23 Mar 2023 · Medicines recall/notification · EL (23)A/12

  Class 2
• Field Safety Notices: 13 to 17 March 2023

  22 Mar 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Rosemont Pharmaceuticals Limited, Sildenafil 10mg/ml Oral Suspension, EL(23)A/11

  21 Mar 2023 · Medicines recall/notification · EL (23)A/11

  Class 3
• Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets, EL(23)A/10

  16 Mar 2023 · Medicines recall/notification · EL (23)A/10

  Class 4
• Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09

  14 Mar 2023 · Medicines recall/notification · EL (23)A/09

  Class 2
• Class 4 Medicines Defect Information: Drugsrus Limited, Clexane 10,000 IU (100mg) / 1ml Syringes, EL(23)A/08

  9 Mar 2023 · Medicines recall/notification · EL (23)A/08

  Class 4
• Class 4 Medicines Defect Information: Thornton & Ross Ltd, Methadone 1mg/mL Oral Solution BP - Sugar Free, Methadone Mixture 1mg/ml , EL(23)A/07

  7 Mar 2023 · Medicines recall/notification · EL (23)A/07

  Class 4
• Field Safety Notices: 27 February to 3 March 2023

  6 Mar 2023 · Field safety notice (devices)

• Class 2 Medicines Recall: Teva UK Limited, Levothyroxine 12.5mcg Tablets, EL (23)A/06

  2 Mar 2023 · Medicines recall/notification · EL (23)A/06

  Class 2
• Field Safety Notices: 20 to 24 February 2023

  27 Feb 2023 · Field safety notice (devices)

• Company led medicines recall: Vertical Pharma Resources Ltd T/A IPS Pharma, Levothyroxine Oral Suspension (Various Strengths) [unlicensed medicine], CLMR(23)A/03

  27 Feb 2023 · Medicines recall/notification

• Class 4 Medicines Defect Information: Atnahs Pharma UK, Zestoretic 20mg/12.5mg Tablets, EL (23)A/05

  27 Feb 2023 · Medicines recall/notification · EL (23)A/05

  Class 4
• Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04

  22 Feb 2023 · Medicines recall/notification · EL (23)A/04

  Class 4
• Field Safety Notices: 13 to 17 February 2023

  20 Feb 2023 · Field safety notice (devices)

• BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above, DSI/2023/004

  20 Feb 2023 · Device safety information

• NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003

  15 Feb 2023 · Device safety information

• Field Safety Notices: 30 January to 3 February 2023

  6 Feb 2023 · Field safety notice (devices)

• National Patient Safety Alert: NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure (NatPSA/2023/003/MHRA)

  1 Feb 2023 · National patient safety alert

• Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid; DSI/2023/002

  31 Jan 2023 · Device safety information

• Field safety notice (FSN) 23 to 27 January 2023

  30 Jan 2023 · Field safety notice (devices)

• Field Safety Notice: 26 January 2023

  26 Jan 2023 · Field safety notice (devices)

• EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs): stop using immediately and quarantine all preloaded EyeCee One lenses DSI/2023/001

  26 Jan 2023 · Device safety information

• Company led medicines recall: Prulab Pharma Limited, Clopidogrel Oral Solution 75mg in 5ml [unlicensed medicine], CLMR (23)A/02

  25 Jan 2023 · Medicines recall/notification

• Field Safety Notices (FSNs) from 22 to 26 January 2024

  20 Jan 2023 · Field safety notice (devices)

• Class 3 Medicines Recall: Dr Reddy’s Laboratories (UK) Ltd, Lacidipine 4 mg Film-Coated Tablets, EL (23)A/03

  19 Jan 2023 · Medicines recall/notification · EL (23)A/03

  Class 3
• Class 2 Medicines Recall: UCB Pharma Ltd, Dioctyl 100 mg Capsules, EL (23)A/02

  18 Jan 2023 · Medicines recall/notification · EL (23)A/02

  Class 2
• Field Safety Notices: 9 to 13 January 2023

  16 Jan 2023 · Field safety notice (devices)

• Company led medicines recall: Mawdsley-Brooks & Company Limited, Fluphenazin-neuraxpharm® D 25 & 100 mg/ml Solution for Injection, CLMR(23)A/01

  12 Jan 2023 · Medicines recall/notification

• Class 4 Medicines Defect Information: Albireo AB, Bylvay 1200 micrograms Hard Capsules, EL (23)A/01

  3 Jan 2023 · Medicines recall/notification · EL (23)A/01

  Class 4

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