← Alert archive

MHRA alerts issued in 2019

121 alerts.

• Field Safety Notice: 23 to 27 December 2019

  30 Dec 2019 · Field safety notice (devices)

• Field Safety Notice: 16 to 20 December 2019

  23 Dec 2019 · Field safety notice (devices)

• Company led drug alert – Paclitaxel 6 mg/ml concentrate for solution for infusion (25ml vials)

  19 Dec 2019 · Medicines recall/notification

• Field Safety Notice: 09 to 13 December 2019

  16 Dec 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Medley Pharma Limited, Ranitidine 150mg Tablets BP, PL 43870/0026, Ranitidine 300mg Tablets BP, PL 43870/0027 (EL(19)A/41)

  16 Dec 2019 · Medicines recall/notification · EL (19)A/41

  Class 2
• BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044)

  12 Dec 2019 · Device safety information

• Field Safety Notice: 02 to 06 December 2019

  9 Dec 2019 · Field safety notice (devices)

• Class 2 Medicines recall: Ranitidine 150mg Film-Coated Tablets, PL 20075/0063, Ranitidine 300mg Film-Coated Tablets, PL 20075/0064 (EL(19)A/40)

  5 Dec 2019 · Medicines recall/notification · EL (19)A/40

  Class 2
• Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041)

  4 Dec 2019 · Device safety information

• Field Safety Notice: 25 to 29 November 2019

  2 Dec 2019 · Field safety notice (devices)

• Class 2 Medicines recall: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (EL(19)A/39)

  28 Nov 2019 · Medicines recall/notification · EL (19)A/39

  Class 2
• Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, EL(19)A/38

  27 Nov 2019 · Medicines recall/notification · EL (19)A/38

  Class 2
• Field Safety Notice: 18 to 22 November

  25 Nov 2019 · Field safety notice (devices)

• Class 2 Medicines recall: Ranitidine 75mg Tablets, (Various Liveries) (EL(19)A/37)

  21 Nov 2019 · Medicines recall/notification · EL (19)A/37

  Class 2
• Field Safety Notice: 11 to 15 November

  18 Nov 2019 · Field safety notice (devices)

• Class 3 Medicines Recall: Folic Acid Tablets BP 5mg, PL 0142/5522, (EL(19)A/35)

  18 Nov 2019 · Medicines recall/notification · EL (19)A/35

  Class 3
• Class 2 Medicines Recall: Ranitidine Oral Solution 30mg/ml, PL 31862/0023, Ranitidine 150mg Tablets, PL 11311/0138 (EL(19)A/36)

  18 Nov 2019 · Medicines recall/notification · EL (19)A/36

  Class 2
• Field Safety Notice: 04 to 08 November 2019

  11 Nov 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Sandoz Limited, Omeprazole 40 mg Powder for Solution for Infusion, PL 04416/0701 (EL(19)A/34)

  11 Nov 2019 · Medicines recall/notification · EL (19)A/34

  Class 2
• Class 2 Medicines Recall: Kyowa Kirin Limited Mitomycin-C Kyowa, All Strengths (see alert for more information), (EL (19)A/33)

  7 Nov 2019 · Medicines recall/notification · EL (19)A/33

  Class 2
• Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, (EL(19)A/32)

  5 Nov 2019 · Medicines recall/notification · EL (19)A/32

  Class 2
• Field Safety Notice: 28 October to 1 November

  4 Nov 2019 · Field safety notice (devices)

• Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039)

  31 Oct 2019 · Device safety information

• Class 2 Medicines Recall: Nutriflex Omega Plus 1250ml, 1875ml and 2500ml, PL 03551/0119, and Nutriflex Omega Special 625ml, 1250ml, 1875ml and 2500ml, PL 03551/0118 and Supplemented Product codes ASNSPOMCA, ASNSPOMSVA, ASNPLOMCA, ASNPLOMSVA (625ml, 1250ml, 1875ml 2500ml) (EL(19)A/31)

  30 Oct 2019 · Medicines recall/notification · EL (19)A/31

  Class 2
• Field Safety Notice: 21 October to 25 October

  28 Oct 2019 · Field safety notice (devices)

• Class 2 Medicines recall: Zantac 75 Relief Tablets, Zantac 75 Tablets, Galpharm Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets, Kirkland Indigestion Relief 75mg Tablets, Morrisons Indigestion & Heartburn Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (EL (19)A/30)

  25 Oct 2019 · Medicines recall/notification · EL (19)A/30

  Class 2
• Class 2 Medicines recall: Ranitidine 150mg/10ml Oral Solution (EL (19)A/29)

  25 Oct 2019 · Medicines recall/notification · EL (19)A/29

  Class 2
• Company led drug alert – Avonex 30 micrograms/0.5ml Solution for Injection

  23 Oct 2019 · Medicines recall/notification

• Class 2 Medicines recall: Sayana Press 104mg/0.65ml (MDR 055-06/19)

  23 Oct 2019 · Medicines recall/notification

  Class 2
• Company led drug alert – Docetaxel Injection 80mg /8ml

  22 Oct 2019 · Medicines recall/notification

• Field Safety Notice: 14 October to 18 October

  21 Oct 2019 · Field safety notice (devices)

• Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg, Ranitidine Effervescent Tablets 300mg (EL (19)A/27)

  17 Oct 2019 · Medicines recall/notification · EL (19)A/27

  Class 2
• Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro-resistant tablets (MDR 025-10/19)

  16 Oct 2019 · Medicines recall/notification

  Class 4
• Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR 127-09/19)

  16 Oct 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 7 October to 11 October

  14 Oct 2019 · Field safety notice (devices)

• Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037)

  10 Oct 2019 · Device safety information

• Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) (MDA/2019/034)

  9 Oct 2019 · Device safety information

• Class 2 Medicines recall: Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24)

  8 Oct 2019 · Medicines recall/notification

  Class 2
• Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit (MDA/2019/033)

  8 Oct 2019 · Device safety information

• Field Safety Notice: 30 September to 04 October

  7 Oct 2019 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19)

  3 Oct 2019 · Medicines recall/notification

  Class 4
• Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use (MDA/2019/032)

  3 Oct 2019 · Device safety information

• Field Safety Notice: 23 to 27 September

  1 Oct 2019 · Field safety notice (devices)

• Field Safety Notice: 16 to 20 September 2019

  23 Sept 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Bisacodyl 10mg Suppositories EL (19)A/22

  23 Sept 2019 · Medicines recall/notification · EL (19)A/22

  Class 2
• Field Safety Notice: 09 to 13 September 2019

  20 Sept 2019 · Field safety notice (devices)

• All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030)

  18 Sept 2019 · Device safety information

• Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution EL (19)A/21

  12 Sept 2019 · Medicines recall/notification · EL (19)A/21

  Class 2
• Field Safety Notice: 02 to 06 September 2019

  9 Sept 2019 · Field safety notice (devices)

• Field Safety Notice: 27 to 30 August 2019

  2 Sept 2019 · Field safety notice (devices)

• Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection (MDA/2019/028)

  27 Aug 2019 · Device safety information

• Field Safety Notice: 19 to 23 August 2019

  27 Aug 2019 · Field safety notice (devices)

• Field Safety Notice: 12 to 16 August 2019

  19 Aug 2019 · Field safety notice (devices)

• Field Safety Notice: 5 to 9 August 2019

  12 Aug 2019 · Field safety notice (devices)

• Field Safety Notice: 29 July to 2 August 2019

  5 Aug 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution (EL (19)A/20)

  30 Jul 2019 · Medicines recall/notification · EL (19)A/20

  Class 2
• Field Safety Notice: 22 to 26 July 2019

  29 Jul 2019 · Field safety notice (devices)

• FMD Alert: Class 2 (EL (19)A/19)

  25 Jul 2019 · Medicines recall/notification · EL (19)A/19

  Class 2
• Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027)

  25 Jul 2019 · Device safety information

• Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes

  24 Jul 2019 · Device safety information

• Class 2 Medicines Recall: Bisacodyl 5mg Gastro-Resistant tablets batch 25074A (MDR 34-04/19)

  24 Jul 2019 · Medicines recall/notification

  Class 2
• Field Safety Notice: 15 to 19 July 2019

  22 Jul 2019 · Field safety notice (devices)

• Field Safety Notice: 8 to 12 July 2019

  15 Jul 2019 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18)

  11 Jul 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 1 to 5 July 2019

  8 Jul 2019 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19)

  8 Jul 2019 · Medicines recall/notification

  Class 4
• Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy (MDA/2019/008)

  4 Jul 2019 · Device safety information

• Field Safety Notice: 24 to 28 June 2019

  4 Jul 2019 · Field safety notice (devices)

• Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons

  4 Jul 2019 · Device safety information

• IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low (MDA/2019/025)

  2 Jul 2019 · Device safety information

• FMD Alert: Class 2 (EL (19)A/15)

  27 Jun 2019 · Medicines recall/notification · EL (19)A/15

  Class 2
• Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024)

  26 Jun 2019 · Device safety information

• Field Safety Notice: 07 to 21 June 2019

  24 Jun 2019 · Field safety notice (devices)

• Company led drug alert – Docetaxel Injection 160mg /16ml and Docetaxel Injection 20mg / 2ml

  24 Jun 2019 · Medicines recall/notification

• Field Safety Notice: 10 to 14 June 2019

  17 Jun 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19)

  13 Jun 2019 · Medicines recall/notification

  Class 2
• Field Safety Notice: 03 to 07 June 2019

  10 Jun 2019 · Field safety notice (devices)

• Field Safety Notice: 27 to 31 May 2019

  3 Jun 2019 · Field safety notice (devices)

• Class 4 Drug Alert, certain Baxter Potassium Chloride containing intravenous infusions

  3 Jun 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 20 to 25 May 2019

  29 May 2019 · Field safety notice (devices)

• Field Safety Notice: 13 to 17 May 2019

  20 May 2019 · Field safety notice (devices)

• Field Safety Notices: 7 to 10 May 2019

  13 May 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19)

  13 May 2019 · Medicines recall/notification

  Class 2
• Field Safety Notice: 29 April to 3 May 2019

  7 May 2019 · Field safety notice (devices)

• Company led drug alert - Macopharma intravenous infusion bags

  7 May 2019 · Medicines recall/notification

• Field Safety Notice: 23 to 26 April 2019

  29 Apr 2019 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Prednisolone 5mg Tablets (MDR 61-04/19)

  26 Apr 2019 · Medicines recall/notification · EL (19)A/11

  Class 4
• Ethicon Curved Intraluminal Staplers – risk of failure of staple lines (MDA/2019/019)

  25 Apr 2019 · Device safety information

• Class 4 Medicines Defect Information: Ativan 4mg/1ml Solution for injection (MDR 57-04/19)

  24 Apr 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 15 to 19 April 2019

  23 Apr 2019 · Field safety notice (devices)

• Field Safety Notice: 8 to 12 April 2019

  15 Apr 2019 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Chloramphenicol 0.5% W/V Antibiotic Eye Drops (MDR 105-03/19)

  9 Apr 2019 · Medicines recall/notification

  Class 4
• Company led drug alert - Nutriflex Omega Special 2500ml PL 03551/0118

  8 Apr 2019 · Medicines recall/notification

• Field Safety Notice: 01 to 05 April 2019

  4 Apr 2019 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Zoledronic acid 5mg solution for infusion (MDR 51-03/19)

  4 Apr 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 25 to 29 March

  1 Apr 2019 · Field safety notice (devices)

• Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment (MDA/2019/018)

  29 Mar 2019 · Device safety information

• Field Safety Notice: 18 to 22 March 2019

  25 Mar 2019 · Field safety notice (devices)

• Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017)

  20 Mar 2019 · Device safety information

• Class 2 Medicines recall: Accord Healthcare Limited - Losartan Potassium 50mg Film-coated Tablets, PL 20075/0022 and Losartan Potassium 100mg Film-coated Tablets, PL 20075/0023

  20 Mar 2019 · Medicines recall/notification

  Class 2
• Field Safety Notice: 11 to 15 March 2019

  19 Mar 2019 · Field safety notice (devices)

• enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device (MDA/2019/015)

  19 Mar 2019 · Device safety information

• Company-led drug alert - Ozurdex implant recall (MDR 95-08/18)

  18 Mar 2019 · Medicines recall/notification · EL (18)A/16

• Field Safety Notice: 4 to 8 March 2019

  11 Mar 2019 · Field safety notice (devices)

• All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed (MDA/2019/014)

  7 Mar 2019 · Device safety information

• Field Safety Notices - 25 February 2019 - 1 March 2019

  4 Mar 2019 · Field safety notice (devices)

• Drug Alert Class 4: Paracetamol Infusion, Accord. (MDR 07-02/19)

  28 Feb 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 18 to 22 February 2019

  25 Feb 2019 · Field safety notice (devices)

• Field Safety Notice: 11 to 15 February 2019

  18 Feb 2019 · Field safety notice (devices)

• Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19)

  18 Feb 2019 · Medicines recall/notification

  Class 4
• Field Safety Notice: 4 to 8 February 2019

  11 Feb 2019 · Field safety notice (devices)

• Field Safety Notices: 28 January to 1 February 2019

  4 Feb 2019 · Field safety notice (devices)

• Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18)

  4 Feb 2019 · Medicines recall/notification

  Class 4
• Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005)

  30 Jan 2019 · Device safety information

• Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts without a scale (MDA/2019/004)

  30 Jan 2019 · Device safety information

• FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive (MDA/2019/003)

  29 Jan 2019 · Device safety information

• Field Safety Notices: 21 to 25 January 2019

  28 Jan 2019 · Field safety notice (devices)

• Field Safety Notices: 14 to 18 January 2019

  21 Jan 2019 · Field safety notice (devices)

• Field Safety Notice: 7-11 January 2019

  14 Jan 2019 · Field safety notice (devices)

• Field Safety Notice: 31 December 2018 to 4 January 2019

  7 Jan 2019 · Field safety notice (devices)

• Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets

  3 Jan 2019 · Medicines recall/notification

  Class 2

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